N/A
Completed N=812
Evaluation of Two Anti-HIV Treatment Strategies in Resource-Limited South African Communities
Source: ClinicalTrials.gov NCT00255840 ↗Enrolled (actual)
812
Serious AEs
34.4%
Results posted
Jun 2011
Primary outcomePrimary: Cumulative Treatment Failure Rate of Participants on First Line Antiretroviral Therapy Monitored by Primary Health Care Nurses (Investigative Arm)is Not Inferior to the Cumulative Treatment Failure Rate of Participants Monitored by Doctors (Control Arm). — 44; 48 Percentage of participants
Summary
The purpose of this study is to determine the effectiveness of several anti-HIV treatment strategies in resource-poor South African communities. The strategies being studied are using specially trained doctors or nurses to administer HIV care.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cumulative Treatment Failure Rate of Participants on First Line Antiretroviral Therapy Monitored by Primary Health Care Nurses (Investigative Arm)is Not Inferior to the Cumulative Treatment Failure Rate of Participants Monitored by Doctors (Control Arm). |
44; 48 | — |
| SECONDARY To Compare Subject Adherence to First Line Antiretroviral Treatment as Measured by Pill Count, Between the Two Primary Health Care Monitoring Models. |
— | — |
| SECONDARY Drug Resistance HIV Mutations, Defined by Demonstration of Virologic Failure |
— | — |
| SECONDARY To Compare the 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. |
— | — |
| SECONDARY To Estimate the Total and Incremental Costs, From the Provider and Societal Perspectives, of the Two Approaches (the Primary Health Care Sister and Doctor) to the Provision of Antiretrovirals in Primary Health Care Services in Each Study Site. |
— | — |
Eligibility Criteria
Inclusion Criteria
- HIV-1 infected
- Current severe CDC Category B AIDS-defining illness (with the exception of a single episode of bacterial sepsis or a single episode of zoster), OR history of a severe CDC Category B or C AIDS-defining illness, OR one CD4 count less than 350 cells/mm3 within 6 months prior to study entry
- Antiretroviral naive. A participant who previously received 6 weeks or less of post-exposure prophylaxis or short course therapy for the prevention of mother-to-child transmission are not excluded. More information on this criterion can be found in the protocol.
- Willing to use acceptable forms of contraception
- Parent or guardian willing to provide informed consent, if applicable
Exclusion Criteria
- Current newly diagnosed CDC Category C AIDS-defining opportunistic infection or condition requiring acute therapy at the time of study entry. More information on this criterion can be found in the protocol.
- Therapy with agents with significant systemic myelosuppressive, neurotoxic, pancreatotoxic, hepatotoxic, or cytotoxic potential within 30 days prior to study entry
- Require certain medications
- Current alcohol or substance abuse that, in the opinion of the investigator, may interfere with the study
- Uncontrolled diarrhea (more than 6 stools per day for 7 consecutive days) within 30 days prior to study entry
- Diagnosis of or suspected acute hepatitis within 30 days prior to study entry
- Signs or symptoms of bilateral peripheral neuropathy of Grade 2 or greater at screening
- Inability to tolerate oral medication
- Any other clinical condition that, in the opinion of the investigator, may interfere with the study
- In the first trimester of pregnancy
Data sourced from ClinicalTrials.gov (NCT00255840). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.