Effectiveness of Antiretroviral Therapy During Acute HIV Infection

HIV Infections Clinical Trial

Official title: A Phase 1 Clinical Trial to Evaluate the Initiation of Treatment Versus no Treatment During Acute HIV-1 Infection

Status Completed

Clinical Trial Summary

This study will determine whether HIV treatment that is initiated during the acute phase of HIV infection, followed by discontinuation of treatment, is effective in reducing the amount of HIV and an increasing the amount of CD4 cells in the blood of people with HIV, compared to the amounts of HIV and CD4 cells in people who do not receive treatment at this stage.

Clinical Trial Description

Antiretroviral (ARV) therapy for the treatment of HIV infection has been remarkably successful in reducing morbidity and mortality in HIV infected people. This treatment still has its shortcomings, however. Individuals receiving ARV treatment are at risk of toxicity, developing drug resistance, and unknown long-term side effects. Therefore, development of alternative treatment strategies is important. A short course of ARV treatment that is initiated during the acute period of HIV infection, followed by treatment cessation may have a substantial impact on controlling infection and delaying the need for lifelong potent ARV therapy. The purpose of this study is to investigate whether treatment initiated during acute HIV infection and followed by a terminal treatment interruption is effective in lowering the viral load set point and raising CD4 cell counts in people with HIV, as compared to those measures in people with HIV who have received no treatment.

Participants in this study will be randomly assigned to one of three groups. Participants in Group A1 will receive ARV therapy for 12 weeks. Participants in Group A2 will receive ARV therapy for 32 weeks. Participants in Group B will not receive any treatment. This study will not provide medications to any of the groups. All groups will be followed for a total of 72 weeks following study entry. Participants will attend between 30 and 36 study visits over the course of the 72 weeks, depending on their study group. Study visits will occur every week for the first 12 weeks and then every 1 to 6 weeks for the remainder of the study. Tests occurring at study visits may include blood tests, investigational immune system tests, and pregnancy tests. Participants will also undergo a complete physical exam and will be asked to provide information about their medical and medication histories. ;

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Communicable Diseases
• HIV Infections
• Infection

• NCT number: NCT00705926
• Study type: Interventional
• Source: Massachusetts General Hospital
• Status: Completed
• Phase: Phase 1
• Start date: October 2008
• Completion date: July 16, 2017