AIDS clinical trials group longitudinal linked randomized trials (ALLRT): rationale, design, and baseline characteristics.

TitleAIDS clinical trials group longitudinal linked randomized trials (ALLRT): rationale, design, and baseline characteristics.
Publication TypeJournal Article
Year of Publication2008
AuthorsSmurzynski M, Collier AC, Koletar SL, Bosch RJ, Wu K, Bastow B, Benson CA
JournalHIV Clin Trials
Volume9
Issue4
Pagination269-82
Date Published2008 Jul-Aug
ISSN1528-4336
KeywordsAdult, Aged, Anti-HIV Agents, Antiretroviral Therapy, Highly Active, CD4 Lymphocyte Count, Cohort Studies, Controlled Clinical Trials as Topic, Female, Guidelines as Topic, HIV Infections, HIV-1, Humans, Male, Middle Aged, Randomized Controlled Trials as Topic, Treatment Outcome, Viral Load
Abstract

PURPOSE: ALLRT is a longitudinal cohort study of HIV-infected subjects prospectively randomized into selected clinical trials for antiretroviral (ARV) treatment-naïve and ARV treatment-experienced individuals conducted by the AIDS Clinical Trials Group (ACTG). We describe the rationale, design, and baseline characteristics of the ALLRT cohort and its potential to address important research questions related to ARV therapy.

METHOD: Standardized visits occur every 16 weeks to evaluate long-term clinical, virologic, and immunologic outcomes associated with ARV treatment.

RESULTS: A total of 4,371 subjects enrolled in ALLRT from January 2000 through June 2007. Of these, 3,146 (72%) were ARV naïve at parent study entry (18% female, 44% white, 32% black, 21% Hispanic; median age 37 years, CD4 count 218 cells/microL, follow-up 3.6 years; 343 [11%] followed > or = 8 years) and 1,225 (28%) were treatment experienced (13% female, 59% white, 20% black, 17% Hispanic; median age 42 years, CD4 count 325 cells/microL, follow-up 5.7 years).

CONCLUSIONS: ALLRT provides the opportunity to understand long-term ramifications of therapeutic ARV choices and determine whether these vary by treatment regimen, timing of treatment initiation, or treatment changes over long-term follow-up. Investigations based on uniform data and specimen collection in the context of randomized ARV treatments will be critical to developing more successful long-term therapeutic strategies for HIV treatment.

DOI10.1310/hct0904-269
Alternate JournalHIV Clin Trials
PubMed ID18753121
PubMed Central IDPMC2704053
Grant List1U01-AI069484 / AI / NIAID NIH HHS / United States
5-M01 RR00044 / RR / NCRR NIH HHS / United States
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