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

This study has been completed.
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:
CIPRA SA
ClinicalTrials.gov Identifier:
NCT00255840
First received: November 16, 2005
Last updated: June 17, 2011
Last verified: June 2011
History of Changes
Results First Received: March 2, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: HIV Infections
Interventions: Behavioral: Monitoring by an HIV-trained medical doctor
Behavioral: Monitoring by an HIV-trained primary care nurse
Drug: Efavirenz
Drug: Lamivudine
Drug: Lopinavir/Ritonavir
Drug: Nevirapine
Drug: Stavudine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
HIV-positive adult participants were recruited from February 2005 to December 2007 from two primary health care clinics, one in Masiphumelele, Cape Town and the other in Soweto, Johannesburg.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Antiretroviral Therapy Monitored by Medical Officer

First line antiretroviral regimen monitored by a HIV-trained medical doctor:

  1. Stavudine (>60 kg: 40 mg twice daily and <60 kg: 30 mg twice daily)
  2. Lamivudine (150mg twice daily) and
  3. Efavirenz (600mg daily). For women of child bearing potential with a CD4+ count <250 cells/mm3, Nevirapine (200 mg daily x 14 days, then 200 mg twice daily) and for women with a CD4+ count > 250 cells/mm3, Lopinavir/ritonavir (400/100mg twice daily).
Antiretroviral Therapy Managed by Primary Health Care Nurse

First line antiretroviral regimen monitored by HIV-trained primary health care nurse:

  1. Stavudine (>60 kg: 40 mg twice daily and <60 kg: 30 mg twice daily)
  2. Lamivudine (150mg twice daily) and
  3. Efavirenz (600mg daily). For women of child bearing potential with a CD4+ count <250 cells/mm3, Nevirapine (200 mg daily x 14 days, then 200 mg twice daily) and for women with a CD4+ count > 250 cells/mm3, Lopinavir/ritonavir (400/100mg twice daily).

Participant Flow:   Overall Study
    Antiretroviral Therapy Monitored by Medical Officer     Antiretroviral Therapy Managed by Primary Health Care Nurse  
STARTED     408     404  
COMPLETED     345     334  
NOT COMPLETED     63     70  
Lost to Follow-up                 10                 14  
Discontinued intervention                 53                 56  



  Baseline Characteristics
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Reporting Groups
  Description
Antiretroviral Therapy Monitored by Medical Officer

First line antiretroviral regimen monitored by a HIV-trained medical doctor:

  1. Stavudine (>60 kg: 40 mg twice daily and <60 kg: 30 mg twice daily)
  2. Lamivudine (150mg twice daily) and
  3. Efavirenz (600mg daily). For women of child bearing potential with a CD4+ count <250 cells/mm3, Nevirapine (200 mg daily x 14 days, then 200 mg twice daily) and for women with a CD4+ count > 250 cells/mm3, Lopinavir/ritonavir (400/100mg twice daily).
Antiretroviral Therapy Managed by Primary Health Care Nurse

First line antiretroviral regimen monitored by HIV-trained primary health care nurse:

  1. Stavudine (>60 kg: 40 mg twice daily and <60 kg: 30 mg twice daily)
  2. Lamivudine (150mg twice daily) and
  3. Efavirenz (600mg daily). For women of child bearing potential with a CD4+ count <250 cells/mm3, Nevirapine (200 mg daily x 14 days, then 200 mg twice daily) and for women with a CD4+ count > 250 cells/mm3, Lopinavir/ritonavir (400/100mg twice daily).
Total Total of all reporting groups

Baseline Measures
    Antiretroviral Therapy Monitored by Medical Officer     Antiretroviral Therapy Managed by Primary Health Care Nurse     Total  
Number of Participants  
[units: participants]
 		  408     404     812  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     408     404     812  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation 		  33.2612388  ± 7.1934154     32.9739630  ± 7.3921786     33.12  ± 7.29  
Gender  
[units: participants]
 		     
Female     276     297     573  
Male     132     107     239  
Region of Enrollment  
[units: participants]
 		     
South Africa     408     404     812  



  Outcome Measures

1.  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).   [ Time Frame: 96 weeks ]
  Show Outcome Measure 1

2.  Secondary:   To Compare Subject Adherence to First Line Antiretroviral Treatment as Measured by Pill Count, Between the Two Primary Health Care Monitoring Models.   [ Time Frame: Throughout study ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Drug Resistance HIV Mutations, Defined by Demonstration of Virologic Failure   [ Time Frame: Throughout the study ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

4.  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.   [ Time Frame: Throughout study ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

5.  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.   [ Time Frame: Throughout study ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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:  
Name/Title: Dr Ian Sanne
Organization: CIPRA-SA
phone: +27 11 276 8800
e-mail: isanne@witshealth.co.za


Publications:

Publications automatically indexed to this study:


Responsible Party: James McIntyre, CIPRA SA
ClinicalTrials.gov Identifier: NCT00255840     History of Changes
Other Study ID Numbers: CIPRA-SA Project 1, U19AI053217, 3-U19-AI053217-03S1, 3-U19-AI053217-04S1, 3-U19-AI053217-04
Study First Received: November 16, 2005
Results First Received: March 2, 2011
Last Updated: June 17, 2011
Health Authority: United States: Federal Government