Outcomes of Anti-HIV Therapy During Early HIV Infection
|ClinicalTrials.gov Identifier: NCT00001093|
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : October 29, 2012
The purpose of this study is to find out if it is effective to give aggressive anti-HIV therapy to patients who have been infected recently with HIV.
Many doctors recommend that patients who have recently been infected with HIV begin anti-HIV treatment as soon as possible. However, early HIV infection is not yet completely understood, so it is not known if this is the best approach. This study will look at the effects of beginning anti-HIV treatment during early HIV infection.
|Condition or disease|
Although many researchers have recommended initiation of aggressive antiretroviral therapy as soon as possible after HIV infection occurs, the tolerability and efficacy of this approach has not been systemically evaluated. Many features of primary HIV pathogenesis are incompletely understood. A more complete understanding of immune dynamics and viral pathogenesis during primary HIV infection is critical to determine optimal treatment intervention strategies. This study will evaluate the outcomes of potent antiretroviral therapy initiated at different stages of primary HIV infection.
Thirty-six of the study patients are coenrolled to ACTG 371 or another treatment protocol. All study drug treatment and toxicity management is performed according to guidelines in these treatment protocols. An untreated cohort of 12 patients is also followed on this study. Patients are stratified at enrollment according to their stage of acute or early HIV infection. Patients are evaluated for virologic, immunologic, and clinical parameters for 96 weeks. In addition, novel studies of source partner identification are proposed. An effort is made to determine the most likely source partner(s) for each study patient on the basis of patient recall of possible exposures. A separate study protocol will evaluate the source partner.
|Study Type :||Observational|
|Estimated Enrollment :||48 participants|
|Official Title:||Outcomes of Antiretroviral Therapy During Primary HIV Infection|
|Study Start Date :||October 1999|
|Study Completion Date :||June 2007|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001093
|United States, California|
|Cedars Sinai Med Ctr|
|Los Angeles, California, United States, 90048|
|San Diego, California, United States, 92103|
|San Francisco Gen Hosp / UCSF AIDS Program|
|San Francisco, California, United States, 94110|
|Principal Investigator:||Susan Little|
|Principal Investigator:||James Kahn|
|Principal Investigator:||Eric Daar|