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HIV Treatment Reinitiation in Women Who Received Anti-HIV Drugs to Prevent Mother-to-Child Transmission of HIV (Nearly Naive)

This study has been completed.
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:
AIDS Clinical Trials Group
ClinicalTrials.gov Identifier:
NCT00442962
First received: March 2, 2007
Last updated: December 22, 2011
Last verified: December 2011
History of Changes
Results First Received: July 13, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: HIV Infections
Interventions: Drug: Efavirenz
Drug: Emtricitabine/Tenofovir disoproxil fumarate

  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 from 3 countries: 6 in the US, 1 in Brazil, 1 in Peru, between May 2007 to December 2009.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
HIV-infected women, at least 16 years of age, whose only prior exposure to anti-retrovirals (ARVs) was for the purpose of prevention of mother-to-child transmission, who now qualify to start ARVs for their own health.

Reporting Groups
  Description
EFV + FTC/TDF Participants will take a daily regimen of efavirenz and emtricitabine/tenofovir disoproxil fumarate for 48 weeks

Participant Flow:   Overall Study
    EFV + FTC/TDF  
STARTED     54  
Primary Outcome Evaluation     52 [1]
COMPLETED     46 [2]
NOT COMPLETED     8  
Pregnancy                 1  
Lost to Follow-up                 7  
[1] Primary outcome evaluation at week 24.
[2] Completed 48 weeks of follow-up.



  Baseline Characteristics
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Reporting Groups
  Description
EFV + FTC/TDF Participants will take a daily regimen of efavirenz and emtricitabine/tenofovir disoproxil fumarate for 48 weeks

Baseline Measures
    EFV + FTC/TDF  
Number of Participants  
[units: participants]
 		  54  
Age  
[units: years]
Mean ± Standard Deviation 		  29  ± 7  
Age, Customized  
[units: participants]
 		 
Between 19 and 25 years     19  
Between 26 and 30 years     16  
Between 31 and 35 years     9  
Between 36 and 40 years     6  
Between 40 and 45 years     4  
Gender  
[units: participants]
 		 
Female     54  
Male     0  
Region of Enrollment  
[units: participants]
 		 
United States     12  
Brazil     22  
Peru     20  
CD4 count, Continuous  
[units: cells/mm^3]
Mean ± Standard Deviation 		  264  ± 104  
CD4 count, Categorical  
[units: participants]
 		 
< 50 cells/mm^3     1  
Between 50 and 99 cells/mm^3     0  
Between 100 and 199 cells/mm^3     15  
Between 200 and 299 cells/mm^3     18  
Between 300 and 399 cells/mm^3     15  
400 or more cells/mm^3     5  
Plasma HIV-1 RNA, Continuous  
[units: log10 copies/mL]
Mean ± Standard Deviation 		  4.5  ± 0.6  
Plasma HIV-1 RNA, Categorical  
[units: participants]
 		 
<= 400 copies/mL     0  
Between 401 and 1000 copies/mL     1  
Between 1001 and 10,000 copies/mL     8  
Between 10,001 and 50,000 copies/mL     20  
Between 50,001 and 75,000 copies/mL     11  
Between 75,001 and 250,000 copies/mL     12  
More than 250,000 copies/mL     2  



  Outcome Measures
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1.  Primary:   Percentage of Participants With Early Virologic Response   [ Time Frame: At Week 24 ]
  Show Outcome Measure 1

2.  Secondary:   Time to First Safety Event   [ Time Frame: Throughout study ]
  Hide Outcome Measure 2

Measure Type Secondary
Measure Title Time to First Safety Event
Measure Description Time from starting study treatment to first grade 3 or 4 sign/symptom or laboratory abnormality and at least one grade higher than baseline. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables.
Time Frame Throughout study  
Safety Issue Yes  

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.
All enrolled participants who started study treatment (which in this case, matches the number of participants enrolled.)

Reporting Groups
  Description
EFV + FTC/TDF Participants will take a daily regimen of efavirenz and emtricitabine/tenofovir disoproxil fumarate for 48 weeks

Measured Values
    EFV + FTC/TDF  
Number of Participants Analyzed  
[units: participants]
 		  54  
Time to First Safety Event  
[units: weeks]
Number ( 95% Confidence Interval ) 		 
5th percentile     4.1  
  ( 0.9 to 24.4 )  
10th percentile     24.4  
  ( 0.9 to NA ) [1]
15th percentile     33.1  
  ( 4.1 to NA ) [2]
[1] Not estimable as the upper limit for survival function at all weeks is above 90%
[2] Not estimable as the upper limit for survival function at all weeks is above 85%

No statistical analysis provided for Time to First Safety Event



3.  Secondary:   Percentage of Participants With Early Virologic Suppression   [ Time Frame: At Weeks 24 ]
  Show Outcome Measure 3

4.  Secondary:   Percentage of Participants With Late Virologic Response   [ Time Frame: At Week 48 ]
  Show Outcome Measure 4

5.  Secondary:   Time to Initial Virologic Response   [ Time Frame: Throughout study ]
  Show Outcome Measure 5

6.  Secondary:   Time to Initial Virological Failure   [ Time Frame: Throughout study ]
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7.  Secondary:   Time to Loss of Virologic Response by Week 48 (Defined by FDA TLOVR Algorithm)   [ Time Frame: Throughout study ]
  Show Outcome Measure 7

8.  Secondary:   Early Changes in CD4 Count From Baseline   [ Time Frame: At weeks 0(baseline), 4, 8, 16, 24 ]
  Show Outcome Measure 8

9.  Secondary:   Percentage of Participants With Late Virologic Suppression   [ Time Frame: At Week 48 ]
  Show Outcome Measure 9

10.  Secondary:   Time to First Dose Modification   [ Time Frame: Throughout study ]
  Show Outcome Measure 10

11.  Secondary:   Late Change in CD4 Count From Baseline   [ Time Frame: At week 48 ]
  Show Outcome Measure 11


  Serious Adverse Events
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  Other Adverse Events
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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.


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.  


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:


Responsible Party: Daniel R. Kuritzkes, M.D., Social & Scientific Systems, Inc.
ClinicalTrials.gov Identifier: NCT00442962     History of Changes
Other Study ID Numbers: ACTG A5227, 1U01AI068636
Study First Received: March 2, 2007
Results First Received: July 13, 2011
Last Updated: December 22, 2011
Health Authority: United States: Federal Government