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Emtricitabine/Tenofovir Disoproxil Fumarate for HIV Prevention in Men (iPrEx)

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ClinicalTrials.gov Identifier: NCT00458393
Recruitment Status : Completed
First Posted : April 10, 2007
Results First Posted : January 24, 2018
Last Update Posted : January 24, 2018
Sponsor:
Collaborator:
Bill and Melinda Gates Foundation
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition: HIV Infections
Interventions: Drug: daily TDF/FTC
Drug: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study recruited HIV uninfected participants whose sexual practices put them at risk for HIV infection. They were recruited from community clinics.

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
TDF/FTC

Daily oral emtricitabine/tenofovir disoproxil fumarate

Emtricitabine/tenofovir disoproxil fumarate: Fixed-dose coformulation of 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate

Placebo

Daily oral placebo

Placebo: Placebo for emtricitabine/tenofovir disoproxil fumarate


Participant Flow:   Overall Study
    TDF/FTC   Placebo
STARTED   1251   1248 
COMPLETED   942   953 
NOT COMPLETED   309   295 
Withdrawal by Subject                67                80 
Physician Decision                31                22 
Relocated                77                81 
Lost to Follow-up                115                92 
Sites marked other on the form.                19                20 



  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
TDF/FTC

Daily oral emtricitabine/tenofovir disoproxil fumarate

Emtricitabine/tenofovir disoproxil fumarate: Fixed-dose coformulation of 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate

Placebo

Daily oral placebo

Placebo: Placebo for emtricitabine/tenofovir disoproxil fumarate

Total Total of all reporting groups

Baseline Measures
   TDF/FTC   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 1251   1248   2499 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      92   7.4%      101   8.1%      193   7.7% 
Between 18 and 65 years      1158  92.6%      1147  91.9%      2305  92.2% 
>=65 years      1   0.1%      0   0.0%      1   0.0% 
Age 
[Units: Years]
Median (Full Range)
 25 
 (18 to 67) 
 24 
 (18 to 63) 
 24 
 (18 to 67) 
Sex/Gender, Customized 
[Units: Participants]
Count of Participants
     
Male Sex at Birth. Identify Trans   155   155   310 
Male Sex at Birth. Identify Female   15   14   29 
Male Sex at Birth. Identify Male   1081   1079   2160 
Region of Enrollment 
[Units: Participants]
     
Ecuador   150   150   300 
United States   113   114   227 
Brazil   186   184   370 
South Africa   45   43   88 
Thailand   57   57   114 
Peru   700   700   1400 


  Outcome Measures

1.  Primary:   HIV Seroconversion   [ Time Frame: Monthly follow-up through a median of 1.2 years ]

2.  Primary:   Grade 1 or Higher Creatinine Toxicity   [ Time Frame: Duration of follow-up, median 1.2 years ]

3.  Primary:   Grade 3 or Higher Phosphorous Toxicity   [ Time Frame: The entire follow-up period, median 1.2 years ]

4.  Primary:   Grade 2, 3, or 4 Laboratory Adverse Events   [ Time Frame: Entire follow-up, median 1.2 years ]

5.  Primary:   Grade 2, 3, or 4 Clinical Adverse Events   [ Time Frame: Entire follow-up, median 1.2 years ]

6.  Secondary:   Hepatitis Flares Among Hepatitis B Virus (HBV) Infected Persons During and After Chemoprophylaxis   [ Time Frame: Quarterly lab tests through a median follow-up of 1.2 years ]

7.  Secondary:   Percentage Change in Bone Mineral Density   [ Time Frame: baseline and week 24. ]

8.  Secondary:   Percentage Change in Body Fat   [ Time Frame: Baseline and Week 24 ]

9.  Secondary:   Percentage Change in Fasting Triglycerides   [ Time Frame: Baseline and Week 24 ]

10.  Secondary:   Percent Change in Total Cholesterol   [ Time Frame: Baseline and Week 24 ]

11.  Secondary:   Viral Load Among HIV Infected Participants   [ Time Frame: At the time closest to HIV detection ]

12.  Secondary:   Among HIV Infected Participants Drug Resistance   [ Time Frame: at the time of HIV acquisition ]

13.  Secondary:   CD4 Count Among HIV Infected Participants   [ Time Frame: at the time infection was detected ]

14.  Secondary:   Proportion of Missed Doses by Pill Count   [ Time Frame: At 24 weeks ]

15.  Secondary:   Percentage of Missed Doses by Estimate During CASI Interview   [ Time Frame: Week 24 ]

16.  Secondary:   Number of Condomless Sexual Partners With HIV Positive or Unknown Status   [ Time Frame: At 24 weeks ]

17.  Secondary:   Total Number of Sexual Partners   [ Time Frame: 24 weeks ]

18.  Secondary:   Condomless Receptive Anal Intercourse in the Previous 12 Weeks With Any Partners Regardless of Status.   [ Time Frame: At 24 weeks ]

19.  Secondary:   Incidence of Confirmed Syphilis During Follow-Up   [ Time Frame: All Follow-Up median of 1.2 years of follow-up ]

20.  Secondary:   Incidence of HSV-2 During the Follow-up Period   [ Time Frame: Total study follow-up, a median of 1.2 years ]

21.  Secondary:   Diagnosis of Gonorrhea During the Follow-up Period   [ Time Frame: All of follow-up period, median of 1.2 years ]


  Serious Adverse Events


  Other Adverse Events


  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

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: David Glidden
Organization: University of California, San Francisco
phone: 415-514-8009
e-mail: david.glidden@ucsf.edu


Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):


Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00458393     History of Changes
Obsolete Identifiers: NCT00350324
Other Study ID Numbers: CO-US-104-0288
10445 ( Registry Identifier: DAIDS ES )
1U01AI064002 ( U.S. NIH Grant/Contract )
iPrEx ( Other Identifier: Study team )
First Submitted: April 6, 2007
First Posted: April 10, 2007
Results First Submitted: December 27, 2016
Results First Posted: January 24, 2018
Last Update Posted: January 24, 2018