Long-Term Data Collection From Participants in Adult AIDS Clinical Trials

Study Overview
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Brief Summary
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The purpose of this study is to determine what combinations of anti-HIV drugs work best in patients treated over several years. The study will also assess the occurrence of side effects and opportunistic infections in patients with low viral loads compared to those with higher viral loads.

Detailed Description
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A compilation of outcomes of various antiretroviral therapies would be beneficial when evaluating which strategies are most effective in long-term treatment of HIV-1. Using data from present and recently completed studies, this study will collect information on therapies and their control of HIV infection and maintenance of durable suppression of HIV-1 replication. No treatment is provided by this study, but patients will continue to receive highly active antiretroviral therapy (HAART) from other studies in which they are coenrolled. Blood and urine collection will occur at study entry and periodically throughout the study. Women may undergo pelvic exams and Pap smears. Portions of blood samples will be stored to evaluate genotypic/phenotypic susceptibility testing. Medical histories, physical exams, and questionnaires will be completed periodically.

Official Title
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Adult AIDS Clinical Trials Group Longitudinal Linked Randomized Trials (ALLRT) Protocol

Conditions
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HIV Infections

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria HIV-1 infected Enrolled in an AIDS Clinical Trial Group (ACTG) parent study and has enrolled in this study on or before the Week 16 visit of the parent study, including the visit window of the parent study. More information on this criterion can be found in the protocol. Willing to provide consent for the release and use of clinical data from the parent study Life expectancy of at least 24 weeks Parent or guardian willing to provide informed consent, if applicable Exclusion Criteria Active alcohol or drug abuse that may interfere with the study

Ages Eligible for Study
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Minimum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successive suppressed viral load measures |  | Measured 144 weeks after randomization | 
| Genotypic or phenotypic resistance |  | Measured at baseline and study completion | 
| Complications of HIV disease, including survival, HIV-related opportunistic infections, HIV-related non-opportunistic complications, adverse effects of antiretroviral therapies of grade three or greater |  | Measured throughout | 
| Absolute number and percentage of CD4 and CD8 T cells |  | Measured 144 weeks after randomization | 
| Absolute number and percentage of naive cells, including CD4, CD45RA, and CD62L cells |  | Measured 144 weeks after randomization | 
| Absolute number and percentage of memory cells, including CD4, CD45RO+, and CD45RA- cells |  | Measured 144 weeks after randomization | 
| Levels of immune activation markers, including CD8, CD38, and HLA-DR cells |  | Measured 144 weeks after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HIV-1 latency or replication in tissue or cellular reservoirs |  | Measured at baseline, Week 16, Week 48, and study completion | 
| Syncytium and non-syncytium inducing (SI/NSI) phenotype |  | Measured at baseline, Week 16, Week 48, and study completion | 
| Metabolic and neurologic complications |  | Measured at baseline, Week 16, Week 48, and study completion | 
| Immune responses to antigens such as cytomegalovirus (CMV), Myobacterium avium complex (MAC), Candida, and HIV |  | Measured 144 weeks after randomization | 
| Plasma concentrations of antiretroviral medications other than nucleoside/tide reverse transcriptase inhibitors (NRTIs) |  | Measured at baseline, Week 16, and study completion | 
| Effect of gender, use of hormonal therapies, presence or absence of menopause on short- and long-term virologic suppression, and pap smear abnormalities |  | Measured at baseline, Week 48, and study completion | 
| Quality of life scores |  | Measured at baseline, Week 48, and study completion | 
| Subject-reported patterns of adherence |  | Measured at baseline, Week 48, and study completion | 
| Estimated inpatient, outpatient, and total costs |  | Measured at study completion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Virus Replication, Treatment Experienced, Treatment Naive, AIDS-Related Opportunistic Infections, HIV-1, Risk Factors, Incidence, RNA, Viral, Anti-HIV Agents, Viral Load, Lipodystrophy, Nervous System, Cardiovascular System, Neurologic Symptoms