Status:
COMPLETED
Strategies for Delivering Anti-HIV Therapy in South Africa
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Eligibility:
All Genders
3+ years
Phase:
NA
Brief Summary
Providing effective anti-HIV therapy in developing countries is challenging. This study will evaluate new strategies for delivering anti-HIV medications to people in South Africa. These strategies inc...
Detailed Description
The benefit of antiretroviral therapy is well established but limited to wealthy nations. A predefined, simple sequence of treatment regimens focused on extending the durability of limited treatment o...
Eligibility Criteria
Inclusion
- Inclusion Criteria for the first person in the household who enters the study:
- HIV infected
- Older than 16 years of age
- History of a severe CDC Category B or C AIDS-defining illness or a CD4 cell count less than 350 cells/mm3 within 6 months prior to study entry
- Have not previously taken anti-HIV medications. People who have taken anti-HIV medications for post-exposure prophylaxis or prevention of mother-to-child transmission may be eligible if the previous exposure did not exceed 6 weeks of nucleoside reverse transcriptase inhibitors or protease inhibitors, or two doses of a non-nucleoside reverse transcriptase inhibitor.
- Inclusion Criteria for children between 3 and 16 years old in a household that has been entered in the study:
- HIV infected
- Live in house with an adult participating in the study
- History of severe CDC Category B or C AIDS-defining illness, with the exception of a single episode of bacterial sepsis or a single episode of Zoster; or one CD4% less than 20% (less than 25% for children 3 to 18 months) obtained within 6 months prior to study entry
- Have not previously taken anti-HIV medications. Children who have taken anti-HIV medications for post-exposure prophylaxis or prevention of mother-to-child transmission may be eligible if the previous exposure did not exceed 6 weeks of nucleoside reverse transcriptase inhibitors or protease inhibitors, or two doses of a non-nucleoside reverse transcriptase inhibitor therapy. Children who received 6 weeks of AZT or a single dose of nevirapine will be included in the study.
- Consent of parent or legal guardian
- Primary caregiver who is willing and able to administer anti-HIV medications
- Exclusion Criteria:
- Newly diagnosed AIDS-defining (CDC Classification C) opportunistic infection or condition requiring acute therapy at the time of enrollment. A stable patient on therapy for more than 7 days may be enrolled. Patients who tuberculosis treatment within 8 weeks of the baseline visit are not excluded.
- Use of medications with significant effect on bone marrow, nervous system, pancreas, or liver within 30 days prior to study entry
- Use of cytotoxic medications within 30 days prior to study entry
- Active alcohol or substance abuse
- Severe diarrhea (more than 6 stools/day for 7 consecutive days) within 30 days prior to study entry
- Acute hepatitis within 30 days prior to study entry
- Bilateral peripheral neuropathy of Grade 2 or greater at the time of screening
- Women in the first trimester of pregnancy
- Women who have failed a lopinavir/ritonavir treatment regimen in Part I and who are either pregnant at entry into Part 2 or are of childbearing potential with a CD4 count of 250 cells/mm3 or more
- Inability to tolerate oral medication
- Any clinical condition that, in the opinion of the investigator, would make the person unsuitable for the study or unable to comply with the dosing requirements
Exclusion
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
End Date :
January 1 2007
Estimated Enrollment :
813 Patients enrolled
Trial Details
Trial ID
NCT00080522
Start Date
February 1 2005
End Date
January 1 2007
Last Update
September 18 2007
Active Locations (2)
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1
University of the Witwatersrand/Clinical HIV Research Unit
Johannesburg, Gauteng, South Africa, 2013
2
University of Cape Town/Masiphumelele
Cape Town, South Peninsula, South Africa, 8005