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Pre-Exposure Prophylaxis to Prevent HIV-1 Acquisition Within HIV-1 Discordant Couples (Partners PrEP)

This study has been completed.
Sponsor:
Collaborator:
Bill and Melinda Gates Foundation
Information provided by (Responsible Party):
Connie Celum, University of Washington
ClinicalTrials.gov Identifier:
NCT00557245
First received: November 8, 2007
Last updated: November 20, 2014
Last verified: November 2014
Results First Received: October 30, 2014  
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
Conditions: HIV-1 Infections
HIV Infections
Interventions: Drug: Tenofovir Disoproxil Fumarate (TDF)
Drug: Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)
Drug: 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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Tenofovir Disoproxil Fumarate (TDF) TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily
Placebo Placebo TDF & Placebo FTC/TDF, 1 tablet each daily.

Participant Flow:   Overall Study
    Tenofovir Disoproxil Fumarate (TDF)     Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)     Placebo  
STARTED     1589     1583     1586  
COMPLETED     1577     1571     1574  
NOT COMPLETED     12     12     12  
Lost to Follow-up                 7                 8                 10  
Ineligible                 5                 4                 2  



  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.
All randomized participants, less those who were found to be ineligible (n=11)

Reporting Groups
  Description
Tenofovir Disoproxil Fumarate (TDF) TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily.
Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily
Placebo Placebo TDF & Placebo FTC/TDF, 1 tablet each daily.
Total Total of all reporting groups

Baseline Measures
    Tenofovir Disoproxil Fumarate (TDF)     Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)     Placebo     Total  
Number of Participants  
[units: participants]
  1584     1579     1584     4747  
Age, Customized  
[units: participants]
       
18-24 years     184     177     172     533  
25-34 years     721     690     688     2099  
35-44 years     480     498     513     1491  
45 years and older     199     214     211     624  
Gender  
[units: participants]
       
Female     598     566     621     1785  
Male     986     1013     963     2962  
Region of Enrollment  
[units: participants]
       
Kenya     700     698     697     2095  
Uganda     884     881     887     2652  
Percentage of participants who had unprotected sex in the past month [1]
[units: percentage¬†of¬†participants]
  28     26     26     80  
[1] The percentage of participants who had any unprotected sex acts in the prior month.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Incidence of HIV-1 Seroconversion Among HIV-1 Uninfected Participants   [ Time Frame: Up to 36 months ]

2.  Primary:   Number of Participants With Serious Adverse Events (SAEs)   [ Time Frame: Up to 36 months ]

3.  Secondary:   Study Drug Adherence: Total Number of Study Drug Doses Taken of the Total Dispensed Doses.   [ Time Frame: Up to 36 months ]

4.  Secondary:   Study Drug Adherence: Self-reported Missed Doses of Study Drug   [ Time Frame: Up to 36 months ]

5.  Secondary:   Number of Seroconverters With an HIV-1 Mutation Conferring Resistance to TDF or FTC   [ Time Frame: Up to 36 months ]

6.  Secondary:   Number of Participants With a Sexually Transmitted Infection (STI) During Follow-up   [ Time Frame: Up to 36 months ]

7.  Secondary:   Prevalence of Unprotected Sex During Follow-up   [ Time Frame: Up to 36 months ]

8.  Secondary:   Congenital Abnormalities Among Infants Born to Female Participants Taking Study Drug.   [ Time Frame: Up to 36 months ]

9.  Secondary:   Length Among Infants Born to Female Participants Taking Study Drug   [ Time Frame: up to 12 months ]

10.  Secondary:   Weight Among Infants Born to Female Participants Taking Study Drug   [ Time Frame: up to 12 months ]

11.  Secondary:   Head Circumference Among Infants Born to Female Participants Taking Study Drug   [ Time Frame: up to 12 months ]


  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: Dr. Connie Celum
Organization: University of Washington
phone: 206-520-3824
e-mail: ccelum@uw.edu


Publications of Results:
Other Publications:
Publications automatically indexed to this study:

Responsible Party: Connie Celum, University of Washington
ClinicalTrials.gov Identifier: NCT00557245     History of Changes
Other Study ID Numbers: 32528-A, IND 75,365;, 07-7454-A-01
Study First Received: November 8, 2007
Results First Received: October 30, 2014
Last Updated: November 20, 2014
Health Authority: United States: Food and Drug Administration
Kenya: Ethical Review Committee
Kenya: Institutional Review Board
Kenya: Pharmacy and Poisons Board
Kenya: Ministry of Health
Uganda: Ministry of Health
Uganda: National Council for Science and Technology
Uganda: National Drug Authority
Uganda: Research Ethics Committee