Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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: October 20, 2014
Last verified: October 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
  Hide Participant Flow

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
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

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
Total Total of all reporting groups

Baseline Measures
    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)     Total  
Number of Participants  
[units: participants]
  73     68     75     67     71     68     422  
Age  
[units: years]
Mean ± Standard Deviation
  27  ± 6     27  ± 5     26  ± 5     26  ± 5     27  ± 6     26  ± 5     27  ± 5  
Age, Customized  
[units: participants]
             
Between 13 and 19 years     2     1     5     3     3     3     17  
Between 20 and 29 years     49     46     53     46     47     48     289  
Between 30 and 39 years     20     20     16     18     19     16     109  
>= 40 years     2     1     1     0     2     1     7  
Gender  
[units: participants]
             
Female     73     68     75     67     71     68     422  
Male     0     0     0     0     0     0     0  
Region of Enrollment  
[units: participants]
             
Haiti     12     11     10     7     9     9     58  
Tanzania     3     1     3     3     2     2     14  
Uganda     17     16     18     17     17     16     101  
South Africa     13     8     10     9     10     10     60  
Malawi     13     14     14     12     17     15     85  
India     15     18     20     19     16     16     104  
Gestational age at NVP dosing, Continuous  
[units: weeks]
Mean ± Standard Deviation
  38  ± 2     39  ± 2     38  ± 2     38  ± 3     38  ± 2     38  ± 2     38  ± 2  
Screening CD4 count Categorical  
[units: participants]
             
250-349 cells/mm^3     15     7     8     6     20     13     69  
350-499 cells/mm^3     24     21     29     29     25     22     150  
>=500 cells/mm^3     34     40     38     32     26     33     203  
Screening CD4 count Continuous  
[units: cells/mm^3]
Mean ± Standard Deviation
  538  ± 244     585  ± 215     537  ± 186     545  ± 191     505  ± 205     566  ± 249     545  ± 216  
Screening HIV-1 RNA Categorical  
[units: participants]
             
<=400 copies/mL     17     13     13     12     12     16     83  
401-999 copies/mL     12     8     7     11     6     4     48  
1000-9999 copies/mL     17     26     33     25     29     18     148  
10000-99999 copies/mL     17     17     18     14     20     26     112  
100000-749999 copies/mL     8     3     4     5     4     4     28  
>=750000 copies/mL     1     0     0     0     0     0     1  
Missing/Unknown     1     1     0     0     0     0     2  
Screening HIV-1 RNA Continuous  
[units: log10┬ácopies/mL]
Mean ± Standard Deviation
  3.50  ± 1.01     3.55  ± 0.90     3.54  ± 0.82     3.50  ± 0.88     3.63  ± 0.90     3.66  ± 0.92     3.56  ± 0.90  
Actual ZDV exposure during pregnancy  
[units: participants]
             
yes     46     47     47     42     43     42     267  
no     27     21     28     25     28     26     155  



  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
  Hide Other Adverse Events

Time Frame From first treatment date to 12 weeks of follow up.
Additional Description Expedited adverse event(AE) reporting followed intensive DAIDS Reporting Level, which included AEs resulting in death, congenital anomalies, fetal losses, significant disabilities, requiring hospitalization, and >=3 grade 3 AEs defined by the "DAIDS Table for Grading the Severity of Adult and Pediatric AEs".

Frequency Threshold
Threshold above which other adverse events are reported   5%  

Reporting Groups
  Description
7-day 3TC/ZDV SD NVP and 3TC/ZDV provided at onset of active labor, followed by 7 days of 3TC/ZDV
21-day 3TC/ZDV SD NVP and 3TC/ZDV provided at onset of active labor, followed by 21 days of 3TC/ZDV
7-day FTC/TDF SD NVP and FTC/TDF provided at onset of active labor, followed by 7 days of FTC/TDF
21-day FTC/TDF SD NVP and FTC/TDF provided at onset of active labor, followed by 21 days of FTC/TDF
7-day LPV/r SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r
21-day LPV/r SD NVP and LPV/r provided at onset of active labor, followed by 21 days of LPV/r

Other Adverse Events
    7-day 3TC/ZDV     21-day 3TC/ZDV     7-day FTC/TDF     21-day FTC/TDF     7-day LPV/r     21-day LPV/r  
Total, other (not including serious) adverse events              
# participants affected / at risk     0/73     0/68     0/75     0/67     0/71     0/68  



  Limitations and Caveats
  Hide 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
No text entered.


  More Information
  Hide More Information

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: October 20, 2014
Health Authority: United States: Food and Drug Administration
United States: Data and Safety Monitoring Board