Status:
COMPLETED
Evaluation of Two Anti-HIV Treatment Strategies in Resource-Limited South African Communities
Lead Sponsor:
CIPRA SA
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Eligibility:
All Genders
16+ years
Phase:
NA
Brief 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 traine...
Detailed Description
The introduction of antiretroviral therapy (ART) for the treatment of HIV has dramatically improved morbidity and mortality for HIV infected people in the developed world. However, research data on th...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
812 Patients enrolled
Trial Details
Trial ID
NCT00255840
Start Date
July 1 2006
End Date
January 1 2009
Last Update
June 21 2011
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