Anti-HIV Treatment Interruptions in HIV Infected Adults in South Africa

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

Summary

HIV infected people often must take anti-HIV drugs for long periods, leading to long-term drug exposure and toxicity. Interruptions in anti-HIV therapy, also known as structured treatment interruptions (STIs), may have few negative health effects and may be helpful to the overall long-term health of HIV-infected people. The purpose of this study is to determine if sequential short-term STIs of antiretroviral therapy (ART) in HIV infected individuals in a resource-constrained environment can retain the immune reconstitution benefits of continuous treatment while potentially lessening rates of toxicity associated with continuous therapy strategies and at the same time, lessen costs associated with ART.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Wistar Institute
• Treatments: Lamivudine; Lopinavir; Ritonavir; Stavudine

Criteria

Inclusion Criteria:

• HIV infected

• CD4 count of 200 to 350 cells/mm3 within 60 days of starting study treatment

• Antiretroviral naive. Participants who have received antiretrovirals through postexposure prophylaxis or short course therapy to prevent mother-to-child transmission are eligible for this study.

• Willing to adhere to study treatment

• Willing to be followed for the duration of this study

Exclusion Criteria:

• History of AIDS-defining illness (CDC category C). Patients with a history of pulmonary tuberculosis are not excluded.

• Newly diagnosed AIDS-defining opportunistic infection or other condition requiring acute therapy at study entry

• Previous therapy with agents with significant myelosuppressive, neurotoxic, pancreatotoxic, hepatotoxic, or cytotoxic potential within 30 days prior to study entry

• History of immunomodulatory therapy within 4 weeks prior to screening, or cannot abstain from immunomodulators during the study

• Previously received rabies vaccine

• Current alcohol or drug abuse that, in the opinion of the investigator, may interfere with the study

• Diarrhea (more than 6 stools per day for 7 consecutive days) within 30 days prior to study entry

• Active or suspected acute hepatitis within 30 days of study entry

• Bilateral peripheral neuropathy of Grade 2 or higher at screening

• Inability to tolerate oral medication

• Any clinical condition that, in the opinion of the investigator, would interfere with the study

• Pregnancy or breastfeeding