NCT00001137

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 5,982 (actual)
• Sponsor: Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections · Network
• Sex: All
• Age: 13 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• HIV Infections

Timeline

• Start date: 2000-01-01
• Primary completion: 2013-11-01
• Completion: 2013-11-01
• First posted: 2001-08-31
• Last updated: 2013-12-06

Locations

77 sites across 2 countries: United States, Puerto Rico