An observational study in HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 3 sites in United States. Open to participants aged 13 Years and older. Per ClinicalTrials.gov, last updated 2012-10-29.
Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Observational
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.
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 48 is below the median of 240 across 2,136 observational studies indexed under Infections.
Browse Infections studies →National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,401 studies on the registry; 179 are open to participants now.
Of its 396 completed or terminated interventional studies of FDA-regulated products, 294 (74%) have results posted.
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Patients may be eligible for this study if they:
Exclusion Criteria
Patients will not be eligible for this study if they:
This study is completed, as verified in Oct 2012. You cannot join it, but the record below documents what was studied.
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National Institute of Allergy and Infectious Diseases (NIAID)