Evaluation of Two Anti-HIV Treatment Strategies in Resource-Limited South African Communities
"Safeguard the Household" - A Study of HIV Antiretroviral Therapy Treatment Strategies Appropriate for a Resource Poor Country
5 other identifiers
interventional
812
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable hiv-infections
Started Jul 2006
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 16, 2005
CompletedFirst Posted
Study publicly available on registry
November 21, 2005
CompletedStudy Start
First participant enrolled
July 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2009
CompletedResults Posted
Study results publicly available
June 16, 2011
CompletedJune 21, 2011
June 1, 2011
2.5 years
November 16, 2005
March 2, 2011
June 17, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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).
Cumulative treatment failure is a composite endpoint made up of death, virological failure, toxicity failure and protocol-defined loss to follow-up failure.
96 weeks
Secondary Outcomes (4)
To Compare Subject Adherence to First Line Antiretroviral Treatment as Measured by Pill Count, Between the Two Primary Health Care Monitoring Models.
Throughout study
Drug Resistance HIV Mutations, Defined by Demonstration of Virologic Failure
Throughout the study
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
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
Study Arms (2)
A
ACTIVE COMPARATORStudy-specified Antiretroviral regimen under care of HIV-trained medical doctor
B
ACTIVE COMPARATORStudy-specified Antiretroviral regimen under care of HIV-trained primary care nurse
Interventions
Participants will receive care from an HIV-trained medical doctor
Participants will receive care from an HIV-trained primary care nurse
400 mg lopinavir/100mg ritonavir tablet taken orally twice daily
200 mg tablet taken orally for 14 days before taking a 200 mg tablet orally twice daily
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (6)
Hosseinipour MC, Kazembe PN, Sanne IM, van der Horst CM. Challenges in delivering antiretroviral treatment in resource poor countries. AIDS. 2002;16 Suppl 4:S177-87. doi: 10.1097/00002030-200216004-00024. No abstract available.
PMID: 12699015BACKGROUNDSanne I, van der Horst C. Research as a path to wide-scale implementation of antiretroviral therapy in Africa. J HIV Ther. 2004 Sep;9(3):65-8.
PMID: 15534564BACKGROUNDWools-Kaloustian K, Kimaiyo S. Extending HIV care in resource-limited settings. Curr HIV/AIDS Rep. 2006 Nov;3(4):182-6. doi: 10.1007/s11904-006-0014-1.
PMID: 17032578BACKGROUNDBrehm JH, Koontz DL, Wallis CL, Shutt KA, Sanne I, Wood R, McIntyre JA, Stevens WS, Sluis-Cremer N, Mellors JW; CIPRA-SA Project 1 Study Team. Frequent emergence of N348I in HIV-1 subtype C reverse transcriptase with failure of initial therapy reduces susceptibility to reverse-transcriptase inhibitors. Clin Infect Dis. 2012 Sep;55(5):737-45. doi: 10.1093/cid/cis501. Epub 2012 May 22.
PMID: 22618567DERIVEDOrrell C, Cohen K, Conradie F, Zeinecker J, Ive P, Sanne I, Wood R. Efavirenz and rifampicin in the South African context: is there a need to dose-increase efavirenz with concurrent rifampicin therapy? Antivir Ther. 2011;16(4):527-34. doi: 10.3851/IMP1780.
PMID: 21685540DERIVEDSanne I, Orrell C, Fox MP, Conradie F, Ive P, Zeinecker J, Cornell M, Heiberg C, Ingram C, Panchia R, Rassool M, Gonin R, Stevens W, Truter H, Dehlinger M, van der Horst C, McIntyre J, Wood R; CIPRA-SA Study Team. Nurse versus doctor management of HIV-infected patients receiving antiretroviral therapy (CIPRA-SA): a randomised non-inferiority trial. Lancet. 2010 Jul 3;376(9734):33-40. doi: 10.1016/S0140-6736(10)60894-X.
PMID: 20557927DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
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.
Results Point of Contact
- Title
- Dr Ian Sanne
- Organization
- CIPRA-SA
Study Officials
- PRINCIPAL INVESTIGATOR
James McIntyre, MBChB, MRCOG
Perinatal HIV Research Unit, Chris Hani Baragwanath Hospital
- PRINCIPAL INVESTIGATOR
Ian Sanne, MBChB
University of the Witwatersrand, Thembaletu Clinic, Helen Joseph Hospital
- PRINCIPAL INVESTIGATOR
Robin Wood, MBChB, FCP (SA)
Department of Medicine, University of Cape Town
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
Study Record Dates
First Submitted
November 16, 2005
First Posted
November 21, 2005
Study Start
July 1, 2006
Primary Completion
January 1, 2009
Study Completion
January 1, 2009
Last Updated
June 21, 2011
Results First Posted
June 16, 2011
Record last verified: 2011-06