Status:
COMPLETED
Anti-HIV Treatment Interruptions in HIV Infected Adults in South Africa
Lead Sponsor:
The Wistar Institute
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 interruption...
Detailed Description
Long-term toxicity and the high cost of medications are two problems faced by HIV infected people taking ART. Previous studies in HIV-infected patients suggest that ART with STIs may decrease drug exp...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00100646
Start Date
March 1 2007
End Date
March 1 2010
Last Update
August 27 2014
Active Locations (1)
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1
University of the Witwatersrand
Johannesburg, South Africa