Comparison of Three Anti-HIV Regimens to Prevent Nevirapine Resistance in Women Who Take Nevirapine During Pregnancy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00099632
First received: December 17, 2004
Last updated: August 12, 2014
Last verified: August 2014
Results First Received: December 6, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: HIV Infections
Interventions: Drug: Emtricitabine/Tenofovir Disoproxil Fumarate
Drug: Lamivudine/Zidovudine
Drug: Lopinavir/Ritonavir
Drug: single dose Nevirapine

  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
Study participants were recruited at 8 sites: 2 from South Africa, 2 from India, and 1 each from Haiti, Uganda, Tanzania, and Malawi, between January 2007 to October 2009.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

62 participants who randomized but did not start study treatment were excluded from the analysis. These 62 participants were either off study prior to delivery or delivered on study but did not take any dose of study treatment.

All the analyses were restricted to the 422 women who received study treatment.


Reporting Groups
  Description
7-day Lamivudine/Zidovudine (3TC/ZDV) SD NVP and 3TC/ZDV provided at onset of active labor, followed by 7 days of 3TC/ZDV.
21-day Lamivudine/Zidovudine (3TC/ZDV) SD NVP and 3TC/ZDV provided at onset of active labor, followed by 21 days of 3TC/ZDV.
7-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) SD NVP and FTC/TDF provided at onset of active labor, followed by 7 days of FTC/TDF.
21-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) SD NVP and FTC/TDF provided at onset of active labor, followed by 21 days of FTC/TDF.
7-day Lopinavir/Ritonavir (LPV/r) SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r.
21-day Lopinavir/Ritonavir (LPV/r) SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r

Participant Flow:   Overall Study
    7-day Lamivudine/Zidovudine (3TC/ZDV)     21-day Lamivudine/Zidovudine (3TC/ZDV)     7-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)     21-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)     7-day Lopinavir/Ritonavir (LPV/r)     21-day Lopinavir/Ritonavir (LPV/r)  
STARTED     73     68     75     67     71     68  
COMPLETED     72     67     72     66     70     66  
NOT COMPLETED     1     1     3     1     1     2  
Lost to Follow-up                 1                 0                 3                 1                 1                 0  
Withdrawal by Subject                 0                 1                 0                 0                 0                 1  
Protocol Violation                 0                 0                 0                 0                 0                 1  



  Baseline Characteristics


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With New Circulating Nonnucleoside Reverse Transcriptase Inhibitor (NNRTI)-Resistant Variants as Detected by Standard Composite (Bulk) Genotyping   [ Time Frame: 2 and 6 weeks after completion of treatment ]

2.  Secondary:   Number of Participants With New Circulating NRTI-resistant Variants Detected by Standard Composite (Bulk) Genotyping.   [ Time Frame: 2 and 6 weeks after completion of treatment ]

3.  Secondary:   Number of Participants With New PI-resistant Variants as Detected by Standard Composite (Bulk) Genotyping.   [ Time Frame: 2 and 6 weeks after completion of treatment ]

4.  Secondary:   Severe (Grade 3) and Higher Adverse Events and Any Grade Adverse Event That Leads to a Treatment Change From First Day of Study Treatment to Week 12   [ Time Frame: From first day of study treatment to week 12 ]

5.  Secondary:   Number of Participants Who Discontinued Study Treatment Prematurely   [ Time Frame: From first day of study treatment to last day of study treatment (up to 21 days) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Clinicaltrials.gov Coordinator
Organization: Center for Biostatistics in AIDS Research, Harvard School of Public Health
phone: (617) 432-2829
e-mail: CBAR.ClinicalTrials.gov@sdac.harvard.edu


Publications:
Publications automatically indexed to this study:

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00099632     History of Changes
Other Study ID Numbers: A5207, 10127, ACTG A5207, MOMS
Study First Received: December 17, 2004
Results First Received: December 6, 2011
Last Updated: August 12, 2014
Health Authority: United States: Food and Drug Administration
United States: Data and Safety Monitoring Board