Overview

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