FEM-PrEP (Truvada®): Study to Assess the Role of Truvada® in Preventing HIV Acquisition in Women

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
FHI 360
ClinicalTrials.gov Identifier:
NCT00625404
First received: February 19, 2008
Last updated: April 22, 2014
Last verified: April 2014
Results First Received: December 9, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: HIV Infections
Interventions: Drug: Truvada
Other: Placebo

  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
No text entered.

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
Truvada Arm Daily single oral tablet of Truvada, a fixed-dose combination of emtricitabine (FTC; 200 mg) and tenofovir disoproxil fumarate (TDF; 300 mg).
Placebo Arm Daily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients.

Participant Flow:   Overall Study
    Truvada Arm     Placebo Arm  
STARTED     1062     1058  
COMPLETED     855     885  
NOT COMPLETED     207     173  



  Baseline Characteristics
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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
Truvada Arm Daily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients.
Placebo Arm Daily single oral tablet of Placebo. Tablets are identical to Truvada tablets in taste and appearance; however, they contain no active ingredients.
Total Total of all reporting groups

Baseline Measures
    Truvada Arm     Placebo Arm     Total  
Number of Participants  
[units: participants]
  1062     1058     2120  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     1062     1058     2120  
>=65 years     0     0     0  
Age  
[units: years]
Median ( Full Range )
  23  
  ( 18 to 35 )  
  23  
  ( 18 to 35 )  
  23  
  ( 18 to 35 )  
Gender  
[units: participants]
     
Female     1062     1058     2120  
Male     0     0     0  



  Outcome Measures
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1.  Primary:   HIV Infection   [ Time Frame: Cumulative HIV infection between enrollment and 52 weeks ]

2.  Primary:   Confirmed Grade 2 or Higher Serum Creatinine Toxicity   [ Time Frame: cumulative toxicity through 52 weeks of product use and 4 weeks post product ]

3.  Primary:   Confirmed Grade 3 or Higher Reduction in Phosphorus   [ Time Frame: Through 52 weeks on product and 4 weeks post-product ]

4.  Primary:   Confirmed Grade 3 or Higher ALT Elevation   [ Time Frame: Through 52 weeks on product and 4 weeks post-product ]

5.  Primary:   Confirmed Grade 3 or Higher AST Elevation   [ Time Frame: Through 52 weeks on product and 4 weeks post-product ]

6.  Secondary:   Plasma HIV RNA Level (HIV-1 Viral Load)   [ Time Frame: up to 16 weeks ]

7.  Secondary:   CD4+ T-cell Count   [ Time Frame: Up to 16 weeks ]

8.  Secondary:   FTC and/or Tenofovir Resistance   [ Time Frame: up to 52 weeks ]

9.  Secondary:   Pregnancy Complications   [ Time Frame: up to 60 weeks ]

10.  Secondary:   Pill Counts and Participant Report of Adherence to Once-daily Pill Taking   [ Time Frame: Up to 52 weeks ]

11.  Secondary:   Participant Report of Change in Number of Sexual Partners   [ Time Frame: Up to 52 weeks ]

12.  Primary:   Frequency and Nature of Adverse Events (AEs) During and Within 4 Weeks After Study Product Administration   [ Time Frame: 10-26 months per site ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Jennifer Deese, Principal Investigator
Organization: FHI 360
phone: 919-544-7040 ext 11292
e-mail: jdeese@fhi360.org


No publications provided by FHI 360

Publications automatically indexed to this study:

Responsible Party: FHI 360
ClinicalTrials.gov Identifier: NCT00625404     History of Changes
Other Study ID Numbers: 10015
Study First Received: February 19, 2008
Results First Received: December 9, 2013
Last Updated: April 22, 2014
Health Authority: United States: Food and Drug Administration
Tanzania: Food & Drug Administration
Kenya: Pharmacy and Poisons Board
South Africa: Medicines Control Council