Strategies for Delivering Anti-HIV Therapy in South Africa

NCT00080522 | Completed

• 2 other identifiers: 5U19AI053217-02CIPRA-SA Project 1
• Study Type: interventional
• Target: 813
• Locations: 1 country
• Sites: 2

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 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.

Conditions

HIV Infections

Keywords

Treatment Naive; Resource Poor Setting; Drug Delivery; Household; South Africa

Outcome Measures

Primary Outcomes (2)

• Cumulative treatment failure rate, determined by comparing a primary health care level first line antiretroviral therapy regimen to a doctor monitored treatment regimen

• 48-week cumulative virology failure rate, determined by comparing community-based directly observed therapy (DOT) by identified and trained community members to continued clinic-based treatment support for subjects who have failed first line therapy

Secondary Outcomes (14)

• Overall clinical safety of antiretroviral therapy, as measured by the occurrence of clinical and laboratory Grade 3 and 4 adverse events, between primary health care monitoring arms in adults and children

• CD4+ count, viral load, drug toxicity, adherence, participation in MTCT programs, intercurrent medical conditions, age as factors potentially contributing to cumulative treatment failure in participants age 16 and older

• cumulative treatment failure rate between groups, defined by clinical staging (CDC and WHO classification) prior to initiation of antiretroviral therapy and monitoring arms in adults and children

• cumulative treatment failure rate of second line therapy from time of Phase 1 randomization in adults and children, between the doctor and the primary health care sister-based monitoring arm

• comparison of immune reconstitution in adults and children, using change in CD4+ percent from baseline between the two treatment monitoring models over the duration of the study

Interventions

Monitoring by HIV-trained primary care nurses BEHAVIORAL

Community-based directly observed therapy (DOT) BEHAVIORAL

stavudine DRUG

lamivudine DRUG

efavirenz DRUG

zidovudine DRUG

didanosine DRUG

lopinavir/ritonavir DRUG

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (2)

University of the Witwatersrand/Clinical HIV Research Unit

Johannesburg, Gauteng, 2013, South Africa

Location

University of Cape Town/Masiphumelele

Cape Town, South Peninsula, 8005, South Africa

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Stavudine; Lamivudine; efavirenz; Zidovudine; Didanosine; Lopinavir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Thymidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dideoxynucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Zalcitabine; Deoxycytidine; Cytidine; Inosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Ribonucleosides; Pyrimidinones

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: April 6, 2004
• First Posted: April 7, 2004
• Study Start: February 1, 2005
• Study Completion: January 1, 2007
• Last Updated: September 18, 2007

Record last verified: 2007-08

Locations

ZA (2)