NCT00255840

"Safeguard the Household" - A Study of HIV Antiretroviral Therapy Treatment Strategies Appropriate for a Resource Poor Country

Completed NA Results posted Last updated 17 June 2011

What this trial tests

NA trial testing Monitoring by an HIV-trained medical doctor in HIV Infections in 812 participants. Completed in 1 January 2009.

Timeline

1 July 2006

Primary endpoint
1 January 2009

1 January 2009

Quick facts

Lead sponsor	CIPRA SA
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	812
Start date	1 July 2006
Primary completion	1 January 2009
Estimated completion	1 January 2009

Drugs / interventions tested

• Monitoring by an HIV-trained medical doctor
• Monitoring by an HIV-trained primary care nurse
• Efavirenz (EFAVIRENZ) — full drug profile →
• Lamivudine (LAMIVUDINE) — full drug profile →
• Lopinavir/Ritonavir
• Nevirapine (NEVIRAPINE) — full drug profile →
• Stavudine — full drug profile →

Conditions studied

• HIV Infections — all drugs for HIV Infections →

Sponsor

CIPRA SA — full company profile →

Who can join

16 and older, any sex, with HIV Infections. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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).
  Time frame: 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.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Nurse versus doctor management of HIV-infected patients receiving antiretroviral therapy (CIPRA-SA): a randomised non-inferiority trial.
   Sanne I, Orrell C, Fox MP, Conradie F, et al · · 2010 · cited 182× · PMID 20557927 · DOI 10.1016/s0140-6736(10)60894-x
2. Frequent emergence of N348I in HIV-1 subtype C reverse transcriptase with failure of initial therapy reduces susceptibility to reverse-transcriptase inhibitors.
   Brehm JH, Koontz DL, Wallis CL, Shutt KA, et al · · 2012 · cited 31× · PMID 22618567 · DOI 10.1093/cid/cis501
3. Deficient reporting and interpretation of non-inferiority randomized clinical trials in HIV patients: a systematic review.
   Hernandez AV, Pasupuleti V, Deshpande A, Thota P, et al · · 2013 · cited 25× · PMID 23658818 · DOI 10.1371/journal.pone.0063272
4. Efavirenz and rifampicin in the South African context: is there a need to dose-increase efavirenz with concurrent rifampicin therapy?
   Orrell C, Cohen K, Conradie F, Zeinecker J, et al · · 2011 · cited 24× · PMID 21685540 · DOI 10.3851/imp1780
5. Streamlining tasks and roles to expand treatment and care for HIV: randomised controlled trial protocol.
   Fairall LR, Bachmann MO, Zwarenstein MF, Lombard CJ, et al · · 2008 · cited 20× · PMID 18433494 · DOI 10.1186/1745-6215-9-21
6. Low dose versus high dose stavudine for treating people with HIV infection.
   Magula N, Dedicoat M. · · 2015 · cited 6× · PMID 25627012 · DOI 10.1002/14651858.cd007497.pub2