Strategies for Delivering Anti-HIV Therapy in South Africa

• Status: Completed
• Trial end date: 2007-01-01
• Target enrollment: 0
• Participant gender: All

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 include using specially trained nurses to administer therapy (rather than doctors), treating all HIV infected members of a household at the same time, and having community members observe patients taking their medications.

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

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Didanosine; Efavirenz; Lamivudine; Lopinavir; Ritonavir; Stavudine; Zidovudine

Criteria

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