Safety, pharmacokinetics, and antiretroviral activity of multiple doses of ibalizumab (formerly TNX-355), an anti-CD4 monoclonal antibody in HIV-1 infected adults

Context: Despite tremendous strides in HIV treatment over the past decade, resistance remains a major problem. A growing number of patients develop resistance and require new therapies to suppress viral replication. ^ Objective: To assess the safety of multiple administrations of the anti-CD4 receptor (anti-CD4) monoclonal antibody ibalizumab given as intravenous (IV) infusions, in three dosage regimens, in subjects infected with human immunodeficiency virus (HIV-1). ^ Design: Phase 1, multi-center, open-label, randomized clinical trial comparing the safety, pharmacokinetics and antiviral activity of three dosages of ibalizumab. ^ Setting: Six clinical trial sites in the United States. ^ Participants: A total of twenty-two HIV-positive patients on no anti-retroviral therapy or a stable failing regimen. ^ Intervention: Randomized to one of two treatment groups in Arms A and B followed by non-randomized enrollment in Arm C. Patients randomized to Arm A received 10 mg/kg of ibalizumab every 7 days, for a total of 10 doses; patients randomized to Arm B received a total of six doses of ibalizumab; a single loading dose of 10 mg/kg on Day 1 followed by five maintenance doses of 6 mg/kg every 14 days, starting at Week 1. Patients assigned to Arm C received 25 mg/kg of ibalizumab every 14 days for a total of 5 doses. All patients were followed for safety for an additional 7 to 8 weeks. ^ Main Outcome Measures: Clinical and laboratory assessments of safety and tolerability of multiple administrations of ibalizumab in HIV-infected patients. Secondary measures of efficacy include HIV-1 RNA (viral load) measurements. ^ Results: 21 patients were treatment-experienced and 1 was naïve to HIV therapy. Six patients were failing despite therapy and 15 were on no current HIV treatment. Mean baseline viral load (4.78 log 10; range 3.7-5.9) and CD4+ cell counts (332/μL; range 89-494) were similar across cohorts. Mean peak decreases in viral load from baseline of 0.99 log10(1.11 log10, and 0.96 log 10 occurred by Wk 2 in Cohorts A, B and C, respectively. Viral loads decreased by >1.0 log10 in 64%; 4 patients viral loads were suppressed to < 400 copies/mL. Viral loads returned towards baseline by Week 9 with reduced susceptibility to ibalizumab. CD4+ cell counts rose transiently and returned toward baseline. Maximum median elevations above BL in CD4+ cell counts for Cohorts A, B and C were +257, +198 and +103 cells/μL, respectively and occurred within 3 Wks in 16 of 22 subjects. The half-life of ibalizumab was 3-3.5 days and elimination was characteristic of capacity-limited kinetics. Administration of ibalizumab was well tolerated. Four serious adverse events were reported during the study. None of these events were related to study drug. Headache, nausea and cough were the most frequently reported treatment emergent adverse events and there were no laboratory abnormalities related to study drug. ^ Conclusions: Ibalizumab administered either weekly or bi-weekly was safe, well tolerated, and demonstrated antiviral activity. Further studies with ibalizumab in combination with standard antiretroviral treatments are warranted.^

HIV incidence estimates and HIV/AIDS concurrent diagnosis in Houston/Harris County

The purpose of this dissertation was to estimate HIV incidence among the individuals who had HIV tests performed at the Houston Department of Health and Human Services (HDHHS) public health laboratory, and to examine the prevalence of HIV and AIDS concurrent diagnoses among HIV cases reported between 2000 and 2007 in Houston/Harris County. ^ The first study in this dissertation estimated the cumulative HIV incidence among the individuals testing at Houston public health laboratory using Serologic Testing Algorithms for Recent HIV Seroconversion (STARHS) during the two year study period (June 1, 2005 to May 31, 2007). The HIV incidence was estimated using two independently developed statistical imputation methods, one developed by the Centers for Disease Control and Prevention (CDC), and the other developed by HDHHS. Among the 54,394 persons who tested for HIV during the study period, 942 tested HIV positive (positivity rate=1.7%). Of these HIV positives, 448 (48%) were newly reported to the Houston HIV/AIDS Reporting System (HARS) and 417 of these 448 blood specimens (93%) were available for STARHS testing. The STARHS results showed 139 (33%) out of the 417 specimens were newly infected with HIV. Using both the CDC and HDHHS methods, the estimated cumulative HIV incidences over the two-year study period were similar: 862 per 100,000 persons (95% CI: 655-1,070) by CDC method, and 925 per 100,000 persons (95% CI: 908-943) by HDHHS method. Consistent with the national finding, this study found African Americans, and men who have sex with men (MSM) accounted for most of the new HIV infections among the individuals testing at Houston public health laboratory. Using CDC statistical method, this study also found the highest cumulative HIV incidence (2,176 per 100,000 persons [95%CI: 1,536-2,798]) was among those who tested in the HIV counseling and testing sites, compared to the sexually transmitted disease clinics (1,242 per 100,000 persons [95%CI: 871-1,608]) and city health clinics (215 per 100,000 persons [95%CI: 80-353]. This finding suggested the HIV counseling and testing sites in Houston were successful in reaching high risk populations and testing them early for HIV. In addition, older age groups had higher cumulative HIV incidence, but accounted for smaller proportions of new HIV infections. The incidence in the 30-39 age group (994 per 100,000 persons [95%CI: 625-1,363]) was 1.5 times the incidence in 13-29 age group (645 per 100,000 persons [95%CI: 447-840]); the incidences in 40-49 age group (1,371 per 100,000 persons [95%CI: 765-1,977]) and 50 or above age groups (1,369 per 100,000 persons [95%CI: 318-2,415]) were 2.1 times compared to the youngest 13-29 age group. The increased HIV incidence in older age groups suggested that persons 40 or above were still at risk to contract HIV infections. HIV prevention programs should encourage more people who are age 40 and above to test for HIV. ^ The second study investigated concurrent diagnoses of HIV and AIDS in Houston. Concurrent HIV/AIDS diagnosis is defined as AIDS diagnosis within three months of HIV diagnosis. This study found about one-third of the HIV cases were diagnosed with HIV and AIDS concurrently (within three months) in Houston/Harris County. Using multivariable logistic regression analysis, this study found being male, Hispanic, older, and diagnosed in the private sector of care were positively associated with concurrent HIV and AIDS diagnoses. By contrast, men who had sex with men and also used injection drugs (MSM/IDU) were 0.64 times (95% CI: 0.44-0.93) less likely to have concurrent HIV and AIDS diagnoses. A sensitivity analysis comparing difference durations of elapsed time for concurrent HIV and AIDS diagnosis definitions (1-month, 3-month, and 12-month cut-offs) affected the effect size of the odds ratios, but not the direction. ^ The results of these two studies, one describing characteristics of the individuals who were newly infected with HIV, and the other study describing persons who were diagnosed with HIV and AIDS concurrently, can be used as a reference for HIV prevention program planning in Houston/Harris County. ^

Evaluation of web-based resources for HIV+ youth

Given current rates of the Human Immunodeficiency Virus (HIV) in youth ages 15–24, comprehensive care is imperative in order to manage the virus and to prevent further transmission. In the past decade, the Internet has become an immensely popular source for information, including health information. Due to the increase in Internet use for this purpose, the assessment of the quality, accuracy, and timeliness of health information on the Internet is necessary since the information delivered may not be current or accurate. The purpose of this study was to determine the quantity and quality of websites containing health information and resources directed specifically towards HIV positive youth. Three general search terms, “HIV + teens”, “HIV teens info”, and “HIV infected teens,” were searched using the current top three search engines: Google, Yahoo!, and MSN/Bing. The first hundred hits of each search were then categorized by type of website. The examination of the search results yielded 7 sites that met the inclusion criteria. These sites were consequently evaluated on functionality and content using an adapted version of a pre-existing instrument. The functionality analysis revealed that no websites that contained self management information were dedicated specifically to HIV positive youth. The content analysis showed that the sites chosen for evaluation were mostly consistent with the guidelines provided by the Department of Health and Human Services. The most discussed topics in the sites included the importance of safer sexual behavior, HIV counseling, partner notification, safer behavior choices, such as condom use, and mental health. These results highlight the need for the development of accessible websites that contain accurate information targeting youth infected with HIV. This study provides a snapshot of the available web-based resources and health information for HIV positive youth, and is relevant for health educators, care providers, researchers, and others intervening with HIV+ youth. ^

Adenovirus-36 infection and obesity related hormones in children

Obesity has a complex, multi-factorial etiology. Infectious agents have recently emerged as a possible contributor to the current obesity epidemic. Seven viruses have demonstrated an association with obesity in animals; however, Adenovirus-36 (Ad-36) is the only known virus associated with obesity in humans. The primary aim of this research was to determine the association between Ad-36 infection and the expression of obesity related hormones in children. Additionally, this study proposed to compare the mean three year change in the level of obesity related hormones between Ad-36 positive and negative children. This study utilized pilot data collected from 98 children at baseline and year three of the Project Heartbeat! cohort. Fasting serum samples were analyzed for the concentration of adiponectin, insulin and leptin. The crude analysis uncovered Ad-36 positive children had significantly lower mean concentrations of insulin (p=0.039) and leptin (p=0.038) at baseline compared to Ad-36 negative children. The results of the adjusted analysis indicated the leptin association with Ad-36 infection at baseline was statistically significant even after controlling for age, sex, ethnicity, and BMI percentile. The longitudinal evaluation revealed individuals with a history of Ad-36 infection experienced a larger mean decrease in adiponectin, a larger mean increase in leptin, and a smaller mean increase in insulin levels over a three year period compared to individuals without a history of infection. These results suggest Ad-36 infection may produce changes in hormone expression. The only statistically significant findings in the crude and adjusted longitudinal analysis occurred at baseline when the children were younger, suggesting physical changes that occur during sexual maturation may mask or enhance Ad-36 induced changes in hormone expression. Furthermore, the longitudinal analysis revealed the duration and course of Ad-36 infection may influence changes in the expression of obesity-related hormones. Taken together, the results of this pilot study are suggestive of an association between Ad-36 infection and the expression of obesity-related hormones.^

HIV prevalence and contextual risk-factors among injection drug users in Harris County, Texas

Injection drug use is the third most frequent risk factor for new HIV infections in the United States. A dual mode of exposure: unsafe drug using practices and risky sexual behaviors underlies injection drug users' (IDUs) risk for HIV infection. This research study aims to characterize patterns of drug use and sexual behaviors and to examine the social contexts associated with risk behaviors among a sample of injection drug users. ^ This cross-sectional study includes 523 eligible injection drug users from Houston, Texas, recruited into the 2009 National HIV Behavioral Surveillance project. Three separate set of analyses were carried out. First, using latent class analysis (LCA) and maximum likelihood we identified classes of behavior describing levels of HIV risk, from nine drug and sexual behaviors. Second, eight separate multivariable regression models were built to examine the odds of reporting a given risk behavior. We constructed the most parsimonious multivariable model using a manual backward stepwise process. Third, we examined whether HIV serostatus knowledge (self-reported positive, negative, or unknown serostatus) is associated with drug use and sexual HIV risk behaviors. ^ Participants were mostly male, older, and non-Hispanic Black. Forty-two percent of our sample had behaviors putting them at high risk, 25% at moderate risk, and 33% at low risk for HIV infection. Individuals in the High-risk group had the highest probability of risky behaviors, categorized as almost always sharing needles (0.93), seldom using condoms (0.10), reporting recent exchange sex partners (0.90), and practicing anal sex (0.34). We observed that unsafe injecting practices were associated with high risk sexual behaviors. IDUs who shared needles had higher odds of having anal sex (OR=2.89, 95%CI: 1.69-4.92) and unprotected sex (OR=2.66, 95%CI: 1.38-5.10) at last sex. Additionally, homelessness was associated with needle sharing (OR=2.24, 95% CI: 1.34-3.76) and cocaine use was associated with multiple sex partners (OR=1.82, 95% CI: 1.07-3.11). Furthermore, twenty-one percent of the sample was unaware of their HIV serostatus. The three groups were not different from each other in terms of drug-use behaviors: always using a new sterile needle, or in sharing needles or drug preparation equipment. However, IDUs unaware of their HIV serostatus were 33% more likely to report having more than three sexual partners in the past 12 months; 45% more likely to report to have unprotected sex and 85% more likely to use drug and or alcohol during or before at last sex compared to HIV-positive IDUs. ^ This analysis underscores the merit of LCA approach to empirically categorize injection drug users into distinct classes and identify their risk pattern using multiple indicators and our results show considerable overlap of high risk sexual and drug use behaviors among the high-risk class members. The observed clustering pattern of drug and sexual risk behavior among this population confirms that injection drug users do not represent a homogeneous population in terms of HIV risk. These findings will help develop tailored prevention programs.^

Is H. pylori infection associated with diarrhea in a cohort of 3- to 8-year-old Colombian children?

The Estudio Comunitario sobre la Salud del Niño cohort study followed 326 3- to 8-year-old Colombian children for 4 years to observe the natural history of Helicobacter pylori infection and identify risk factors for acquisition, recurrence and persistence. Acute H. pylori infection during childhood may predispose to other enteric infections and therefore increase the risk of diarrheal disease. This dissertation aimed to estimate the effect of H. pylori infection on the occurrence of diarrhea and parasitic co-infections. The analysis used Generalized Estimating Equations to obtain odds ratios to estimate relative risks for diarrhea and the Zhang-Yu algorithm to estimate relative risks for on parasitic infections. Andersen-Gill models were used to estimate rate ratios for the effect of H. pylori status on the recurrence of parasitic infections. H. pylori status was classified for the entire follow-up duration in 1 of 3 categories: persistently positive, intermittently positive, and persistently negative. Multivariable models included child’s sex, age, symptoms, medication use, and socio-environmental factors. H. pylori infection was weakly and imprecisely associated with diarrheal disease, which occurred at an unexpectedly low frequency in this study. Persistently H. pylori-positive children had a somewhat higher incidence of reported diarrhea than intermittently positive or persistently negative children. Stratified analysis revealed that the presence of specific helminthes modified the effect of persistent H. pylori infection on diarrhea. The incidence of any parasitic infections was higher in children with persistent H. pylori infection relative to those with intermittent or persistently negative status, but this association did not hold when adjusted for the full set of selected covariates. The effects of H. pylori persistent status were similar for the occurrence or recurrence of Giardia duodenalis, Entamoeba histolytica, and Ascaris lumbricoides. These results show that H. pylori frequently co-exists with other parasites in Andean children and suggest that intermittently H. pylori–positive children might be at a lower risk of parasitic infections than persistently positive children. The relationship of H. pylori infection, helminthic infection and diarrheal disease should be further explored in studies that devote more intensive resources to accurate ascertainment of diarrhea.^

Adherence to HIV /AIDS therapies among low -literacy populations: The ALP project

Adherence to HIV/AIDS therapies has been an important health problem since the early 1980s when AZT was first prescribed as a therapy for HIV/AIDS. It became particularly important between 1995 and 1997 with the advent of protease inhibitors (Chesney, Ickovics, Hecht, Sikipa, & Rabkin J., 1999) and became even more significant as persons with HIV/AIDS began to develop resistance to medications. Low-literacy populations have poorer health (Brez & Taylor, 1997) and higher AIDS rates (Simon, Hu, Diaz, & Kerndt, 1995), than their higher literacy counterparts due to delayed treatment (Baker, Parker, Williams, Clark, & Nurss, 1997), shame of literacy skills (Parikh, 1996), and poor access to care (Williams, et al., 1995). Poorer health and higher AIDS rates can also be attributed to poor patient-provider relationships (Crespo-Fierro, 1997; Eldred, Wu, Chaisson, & Moore, 1998) to a poorer understanding of medical protocols (Murphy, 1997), and inadequate patient education (Ungvarski, 1997; Davis, Michielutte, Askov, Williams, & Weiss, 1998, Doak, Doak, & Root, 1996). ^ The ALP intervention was developed for HIV positive low-literacy populations of African American women in Houston, Texas. The intervention was based on a needs assessment, using the PRECEDE model, an innovative process referred to as Intervention Mapping, and validated using formative evaluation methods with 54 individuals. The needs assessment resulted in a list of behavioral, environmental, predisposing, enabling, and reinforcing determinants of adherence. The Intervention Mapping framework was used to refine these determinants and develop a list of objectives describing what must be learned or changed to for the target population to adhere to HIV/AIDS therapies. Methods and strategies, were developed using theoretical constructs from the Health Belief Model (Rosenstock, 1974) and Social Cognitive Theory (Bandura, 1986). These theories, empirical evidence, and information from the target population indicated that perceived susceptibility, perceived severity, outcome expectations, and self-efficacy were important and changeable determinants of adherence to HIV/AIDS therapies for this population. ^ These components were brought together in the form of a theory-based color cartoon book and 10-minute cassette tape. The book was developed for people with 2.9 years of U.S. education as measured with the Flesch-Kincaid Grade Level method and the script was recorded onto a cassette tape to make it suitable for populations with even lower-literacy skills. A formative evaluation was conducted to ensure that the content and structure were accurate, clear, realistic, readable, appropriate, and likely to be used as intended. ^

Stigma, social relationship and HIV testing in the workplace : evidence from South Africa

This paper explores whether a worker's unwillingness to make his/her HIV-positive status or test-taking experience known by colleagues impedes his/her decision to test for HIV. After analyzing the new survey data provided by employees working for a large multinational enterprise in South Africa (2009-2010), this study finds that this unwillingness is negatively associated with test-taking (at the enterprise's on-site clinic) of workers who are extensively networked with close colleagues (i.e., know their phone numbers). It appears that the expected disutility associated with HIV/AIDS-related stigma prohibits test uptake. When introducing HIV counseling and testing programs into a corporate sector, providing all workers with an excuse to test in the workplace and/or inducing them to privately test outside the workplace may be effective in encouraging the uptake.

Stable exposure of the coreceptor-binding site in a CD4-independent HIV-1 envelope protein

We recently derived a CD4-independent virus from HIV-1/IIIB, termed IIIBx, which interacts directly with the chemokine receptor CXCR4 to infect cells. To address the underlying mechanism, a cloned Env from the IIIBx swarm (8x) was used to produce soluble gp120. 8x gp120 bound directly to cells expressing only CXCR4, whereas binding of IIIB gp120 required soluble CD4. Using an optical biosensor, we found that CD4-induced (CD4i) epitopes recognized by mAbs 17b and 48d were more exposed on 8x than on IIIB gp120. The ability of 8x gp120 to bind directly to CXCR4 and to react with mAbs 17b and 48d in the absence of CD4 indicated that this gp120 exists in a partially triggered but stable state in which the conserved coreceptor-binding site in gp120, which overlaps with the 17b epitope, is exposed. Substitution of the 8x V3 loop with that from the R5 virus strain BaL resulted in an Env (8x-V3BaL) that mediated CD4-independent CCR5-dependent virus infection and a gp120 that bound to CCR5 in the absence of CD4. Thus, in a partially triggered Env protein, the V3 loop can change the specificity of coreceptor use but does not alter CD4 independence, indicating that these properties are dissociable. Finally, IIIBx was more sensitive to neutralization by HIV-positive human sera, a variety of anti-IIIB gp120 rabbit sera, and CD4i mAbs than was IIIB. The sensitivity of this virus to neutralization and the stable exposure of a highly conserved region of gp120 suggest new strategies for the development of antibodies and small molecule inhibitors to this functionally important domain.

Persistence of immunoglobulin heavy chain/c-myc recombination-positive lymphocyte clones in the blood of human immunodeficiency virus-infected homosexual men.

We studied blood lymphocytes of human immunodeficiency virus (HIV)-seropositive and -negative homosexual men for the presence of T(8;14) translocations that recombine c-myc and immunoglobulin heavy-chain (IgH) mu/IgH alpha switch regions. Clones with T(8;14) translocations were detected in 10.5% (12/114) of the HIV-positive and in 2.0% of the 99 uninfected patients. The majority of recombinations were found at a single time point only. Four patients, however, harbored multiple (up to four) and persistent (up to 9 years) translocation-positive cell clones. No correlation between the presence of these aberrant lymphocytes and a later lymphoma could be established. The exon 1/intron 1 region of the recombined c-myc was investigated for the presence of point mutations and these were found in the nonpersistent clones. Additional alterations detected in these clones included duplications and a deletion in the c-myc gene. The pattern of base substitution indicates that they were introduced after the translocation event.

Teste anti-HIV entre homens que fazem sexo com homens em São Paulo: busca espontânea rotineira e episódica

Introdução No contexto da valorização crescente do teste anti-HIV como estratégia de prevenção programática, a promoção do teste anti-HIV como estratégia de prevenção entre homens que fazem sexo com homens (HSH) é fundamental. Objetivo - Analisar os fatores associados tanto ao uso rotineiro como episódico do teste anti-HIV. Métodos - Os participantes foram 946 HSH entrevistados pelo Projeto SampaCentro em locais de sociabilidade HSH da região central de São Paulo entre novembro de 2011 e janeiro de 2012, nunca testados ou que procuraram o teste espontaneamente. A metodologia de amostragem foi a time-space-sampling e foram utilizados protocolos do Stata 12.0 para análise de amostras complexas. Os homens que se testaram por rotina ou episodicamente foram comparados aos nunca testados. As variáveis analisadas nos dois modelos de regressão de Poisson foram divididas em três níveis: características sociodemográficas (primeiro nível); socialização na comunidade gay e exposição da orientação sexual, discriminação e opiniões e atitudes em relação ao HIV/Aids e ao teste (segundo nível); percepção de risco, estratégias de prevenção e práticas e parcerias sexuais (terceiro nível). Resultados Os homens que se testaram rotineiramente eram mais velhos e moradores no Centro de SP. Além disso, tinham exposto a orientação sexual para profissional de saúde, sido discriminados em serviços de saúde mas não por amigos e/ou vizinhos (em razão da sexualidade) e não mencionaram medo do resultado do teste como motivo para HSH não se testarem. Também tinham maior probabilidade de conhecer pessoa soropositiva e de ter parcerias estáveis sem sexo anal desprotegido nas casuais (comparado a ter apenas parcerias casuais protegidas). Os homens que se testaram episodicamente eram mais velhos, residentes do Centro de SP, não moravam com parentes, expuseram sua orientação sexual para profissional de saúde, não reportaram medo do resultado do teste como barreira, conheciam pessoa soropositiva e mencionaram parceria estável sem sexo desprotegido com parceiro casual ou então sexo desprotegido em parcerias casuais (comparado a ter apenas parcerias casuais protegidas). Conclusões Os mais jovens, os que moram fora do centro de São Paulo, e os que expões menos sua orientação sexual são os segmentos que menos se testam rotineira ou episodicamente. Assim, dependem de ações para que seu direito seja protegido e assegurado. A estigmatização e a discriminação da homossexualidade deve ser combatida para que não impeça o acesso ao teste e a outros serviços de saúde. Disseminar informações e socializar os mais jovens para o diálogo sobre as estratégias de prevenção biomédicas e estratégias comunitárias de prevenção é necessário. Para ampliar o acesso e qualidade da testagem como recurso fundamental de programas de prevenção permanece o desafio de sustentar o debate sobre sexualidade e prevenção a cada geração, assim como nos programas de formação de educadores e de profissionais de saúde de todas as áreas.

Personalidade e Adesão ao tratamento em pacientes adultos jovens portadores de HIV

Objetivos: Este trabalhado teve como objetivo avaliar a relação entre características de personalidade e adesão ao tratamento antirretroviral em pacientes jovens adultos (18 a 32 anos) portadores do HIV. Metodologia: A adesão ao tratamento foi avaliada pelo \"Cuestionario para la Evaluación de la Adhesión al Tratamiento Antirretrovial (CEAT) e as características de personalidade foram avaliadas pela Bateria Fatorial de Personalidade (BFP). Resultados: A amostra foi composta por 51 pacientes e a análise dos dados sugere que o fator de personalidade associado a adesão ao tratamento é Realização. Este fator também surge como preditor independente para adesão ao tratamento. Discussão: Tais resultados reforçam a necessidade de inclusão destes aspectos na avaliação integral realizada pela equipe de saúde ao paciente jovem portador do vírus HIV. Os dados também reforçam a importância do profissional da área de psicologia como parte da equipe visto que, com o acompanhamento psicológico, é possível ajustar e modificar tais características, desenvolvendo estratégias de atendimento mais eficazes

Host and Environmental Correlates of Multi-Drug Resistance in Kenyan Children with Acute Bacterial Diarrhea

Thesis (Master's)--University of Washington, 2016-06

HIV Status and Risk Factors for Hypertension in South African Adults

Thesis (Master's)--University of Washington, 2016-06

Increased health care utilization and increased antiretroviral use in HIV-infected individuals with mental health disorders

Objectives The aims of the study were to describe the prevalence and associations of mental health disorder (MHD) among a cohort of HIV-infected patients attending the Victorian HIV/AIDS Service between 1984 and 2000, and to examine whether antiretroviral therapy use or mortality was influenced by MHD (defined as a record of service provision by psychiatric services on the Victorian Psychiatric Case Register). It was hypothesized that HIV-positive individuals with MHD would have poorer treatment outcomes, reduced responses to highly active antiretroviral therapy (HAART) and increased mortality compared with those without MHD. Methods This is a retrospective cohort of 2981 individuals (73% of the Victorian population diagnosed with HIV infection) captured on an HIV database which was electronically matched with the public Victorian Psychiatric Case Register (VPCR) (accounting for 95% of public system psychiatry service provision). The prevalence, dates and recorded specifics of mental health disorders at the time of the electronic match on 1 June 2000 are described. The association with recorded MHD, gender, age, AIDS illness, HIV exposure category, duration and type of antiviral therapy, treatment era (prior to 1986, post-1987 and pre-HAART, and post-HAART) on hospitalization and mortality at 1 September 2001 was assessed. Results Five hundred and twenty-five individuals (17.6% of the Victorian HIV-positive population) were recorded with MHD, most frequently coded as attributable to substance dependence/abuse or affective disorder. MHD was diagnosed prior to HIV in 33% and, of those diagnosed after HIV, 93.8% were recorded more than 1 year after the HIV diagnosis. Schizophrenia was recorded in 6% of the population with MHD. Hospitalizations for both psychiatric and nonpsychiatric illness were more frequent in those with MHD (relative risk 5.4; 95% confidence interval 3.7, 8.2). The total number of antiretrovirals used (median 6.4 agents vs 5.5 agents) was greater in those with MHD. When adjusted for antiretroviral treatment era, HIV exposure category, CD4 cell count and antiretroviral therapy, survival was not affected by MHD. Conclusions MHD is frequent in this population with HIV infection and is associated with increased healthcare utilization but not with reduced survival.