Evaluation of Two Anti-HIV Treatment Strategies in Resource-Limited South African Communities

• Status: Completed
• Trial end date: 2009-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the effectiveness of several anti-HIV treatment strategies in resource-poor South African communities. The strategies being studied are using specially trained doctors or nurses to administer HIV care.

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

Details

• Lead Sponsor: CIPRA SA
• Collaborator: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Efavirenz; Lamivudine; Lopinavir; Nevirapine; Ritonavir; Stavudine

Criteria

Inclusion Criteria:

• HIV-1 infected

• Current severe CDC Category B AIDS-defining illness (with the exception of a single episode of bacterial sepsis or a single episode of zoster), OR history of a severe CDC Category B or C AIDS-defining illness, OR one CD4 count less than 350 cells/mm3 within 6 months prior to study entry

• Antiretroviral naive. A participant who previously received 6 weeks or less of post-exposure prophylaxis or short course therapy for the prevention of mother-to-child transmission are not excluded. More information on this criterion can be found in the protocol.

• Willing to use acceptable forms of contraception

• Parent or guardian willing to provide informed consent, if applicable

Exclusion Criteria:

• Current newly diagnosed CDC Category C AIDS-defining opportunistic infection or condition requiring acute therapy at the time of study entry. More information on this criterion can be found in the protocol.

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

• Require certain medications

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

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

• Diagnosis of or suspected acute hepatitis within 30 days prior to study entry

• Signs or symptoms of bilateral peripheral neuropathy of Grade 2 or greater at screening

• Inability to tolerate oral medication

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

• In the first trimester of pregnancy