Trial · NCT00255840

Evaluation of Two Anti-HIV Treatment Strategies in Resource-Limited South African Communities

NCT00255840, Not applicable, Completed, CIPRA SA; results first posted 2011-06-16

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Evaluation of Two Anti-HIV Treatment Strategies in Resource-Limited South African Communities. Trials, record NCT00255840. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00255840

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Evaluation of Two Anti-HIV Treatment Strategies in Resource-Limited South African Communities
NCT number: NCT00255840
Status: Completed
Phases: Not applicable
Enrollment: 812 participants, actual
Lead sponsor: CIPRA SA
Conditions: HIV Infections
Interventions: Monitoring by an HIV-trained medical doctor, Monitoring by an HIV-trained primary care nurse, Efavirenz, Lamivudine, Lopinavir/Ritonavir, Nevirapine, Stavudine
First posted: 2005-11-21
Last updated: 2011-06-21
Results first posted: 2011-06-16
Limitations and caveats: The study design did not address nurse-initiated ART because the prescription of ART in South Africa is restricted to doctors. We noted a high rate of loss to follow-up, but this rate was similar to other resource-constrained settings.

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
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).	96 weeks	Cumulative treatment failure is a composite endpoint made up of death, virological failure, toxicity failure and protocol-defined loss to follow-up failure.
Secondary	To Compare Subject Adherence to First Line Antiretroviral Treatment as Measured by Pill Count, Between the Two Primary Health Care Monitoring Models.	Throughout study
Secondary	Drug Resistance HIV Mutations, Defined by Demonstration of Virologic Failure	Throughout the study
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.	Throughout study
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.	Throughout study

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
SECONDARY	To Compare Subject Adherence to First Line Antiretroviral Treatment as Measured by Pill Count, Between the Two Primary Health Care Monitoring Models.	Throughout study
SECONDARY	Drug Resistance HIV Mutations, Defined by Demonstration of Virologic Failure	Throughout the study
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.	Throughout study
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.	Throughout study
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).	96 weeks	The primary analysis was an intention-to-treat analysis of any treatment failure with use of Cox proportional hazards regression.	Percentage of participants	NUMBER

Source ClinicalTrials.gov

Results by group2

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
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).	Antiretroviral Therapy Monitored by Medical Officer		44	95% Confidence Interval 39 to 49	Percentage of participants
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).	Antiretroviral Therapy Managed by Primary Health Care Nurse		48	95% Confidence Interval 43 to 52	Percentage of participants

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Antiretroviral Therapy Monitored by Medical Officer	408
Overall Study	STARTED	Antiretroviral Therapy Managed by Primary Health Care Nurse	404
Overall Study	COMPLETED	Antiretroviral Therapy Monitored by Medical Officer	345
Overall Study	COMPLETED	Antiretroviral Therapy Managed by Primary Health Care Nurse	334
Overall Study	NOT COMPLETED	Antiretroviral Therapy Monitored by Medical Officer	63
Overall Study	NOT COMPLETED	Antiretroviral Therapy Managed by Primary Health Care Nurse	70

Source ClinicalTrials.gov

Adverse events234

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Neutropenia	Blood and lymphatic system disorders	Antiretroviral Therapy Monitored by Medical Officer	27	408	34
other	Neutropenia	Blood and lymphatic system disorders	Antiretroviral Therapy Managed by Primary Health Care Nurse	17	404	22
other	GGT increased	Investigations	Antiretroviral Therapy Monitored by Medical Officer	29	408	36
other	GGT increased	Investigations	Antiretroviral Therapy Managed by Primary Health Care Nurse	15	404	20
other	Hyperlactatemia	Metabolism and nutrition disorders	Antiretroviral Therapy Monitored by Medical Officer	71	408	79
other	Hyperlactatemia	Metabolism and nutrition disorders	Antiretroviral Therapy Managed by Primary Health Care Nurse	43	404	44
other	Lipodystrophy	Skin and subcutaneous tissue disorders	Antiretroviral Therapy Monitored by Medical Officer	39	408	40
other	Lipodystrophy	Skin and subcutaneous tissue disorders	Antiretroviral Therapy Managed by Primary Health Care Nurse	34	404	35
other	Peripheral Neuropathy	Nervous system disorders	Antiretroviral Therapy Monitored by Medical Officer	28	408	29
other	Peripheral Neuropathy	Nervous system disorders	Antiretroviral Therapy Managed by Primary Health Care Nurse	10	404	10

1 to 10 of 234Source ClinicalTrials.gov

See all 234 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Antiretroviral Therapy Monitored by Medical Officer
Total, all-cause mortality	Antiretroviral Therapy Managed by Primary Health Care Nurse
Total, other adverse events	Antiretroviral Therapy Monitored by Medical Officer	194	408
Total, other adverse events	Antiretroviral Therapy Managed by Primary Health Care Nurse	119	404
Total, serious adverse events	Antiretroviral Therapy Monitored by Medical Officer	126	408
Total, serious adverse events	Antiretroviral Therapy Managed by Primary Health Care Nurse	153	404

Source ClinicalTrials.gov

Papers6

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
12699015	BACKGROUND	PubMed
15534564	BACKGROUND	PubMed
17032578	BACKGROUND	PubMed
20557927	DERIVED	PubMed
21685540	DERIVED	PubMed
22618567	DERIVED	PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
U19AI053217	CIPRA-SA: Safeguard the household: comprehensive AIDS research: Extension	MCINTYRE, JAMES ALASDAIR	WITS HEALTH CONSORTIUM (PTY), LTD	NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES	2002 to 2011

Source NIH RePORTER

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Antiretroviral Therapy Monitored by Medical Officer vs Antiretroviral Therapy Managed by Primary Health Care Nurse: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00255840

GET https://conductscience.org/api/trials/v1/NCT00255840/events?page=2

API reference For AI assistants