Extended Safety Study of Tenofovir Disoproxil Fumarate (TDF) Among HIV-1 Negative Men

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00131677
Recruitment Status : Completed
First Posted : August 19, 2005
Results First Posted : March 10, 2014
Last Update Posted : March 10, 2014
San Francisco Department of Public Health
AIDS Research Consortium of Atlanta
Information provided by (Responsible Party):
Centers for Disease Control and Prevention

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition: HIV Infection
Interventions: Drug: tenofovir disoproxil fumarate
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

Recruitment began in 1/2005 and was completed in 7/2007. Participant follow-up was completed in July 2009.

Participants were recruited from:

San Francisco Dept. of Public Health AIDS Research Consortium of Atlanta Fenway Health

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
After an initial screening visit, participants were required to meet all enrollment criteria again at the enrollment visit.

Reporting Groups
Tenofovir Disoproxil Fumarate Participants received TDF 300mg orally daily for 24 months (immediate arm) or 15 months (delayed arm).
Placebo Participants received matching placebo, to be taken daily.

Participant Flow:   Overall Study
    Tenofovir Disoproxil Fumarate   Placebo
STARTED   201 [1]   199 [2] 
COMPLETED   171   160 
NOT COMPLETED   30   39 
[1] 201 randomized to active drug; 101 to start immediately and 100 after a 9 month delay.
[2] 199 randomized to placebo; 99 to start immediately and 100 after a 9 month delay.

  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.
400 participants enrolled (200 in San Francisco, 121 in Atlanta, and 79 in Boston). 201 were randomized to TDF and 199 to placebo. Participants were distributed similarly in terms of age, ethnicity, education, no. male partners in previous 3 mo., and no. of unprotected anal sexual contacts within the previous 3 mo.

Reporting Groups
Tenofovir Disoproxil Fumarate Active arm: assigned to take TDF, 300mg po daily.
Placebo Placebo arm--received matching placebo
Total Total of all reporting groups

Baseline Measures
   Tenofovir Disoproxil Fumarate   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 201   199   400 
[Units: Participants]
<=18 years   0   0   0 
Between 18 and 65 years   201   199   400 
>=65 years   0   0   0 
[Units: Years]
Mean (Standard Deviation)
 38.7  (9.3)   36.7  (11.0)   37.7  (10.2) 
[Units: Participants]
Female   0   0   0 
Male   201   199   400 
Region of Enrollment 
[Units: Participants]
United States   201   199   400 

  Outcome Measures

1.  Primary:   Clinical Safety--Creatinine Elevations   [ Time Frame: 24 months (immediate arm) and 15 months (delayed arm) ]

2.  Primary:   Clinical Safety--Hypophosphatemia   [ Time Frame: 24 months (immediate arm), 15 months (delayed arm) ]

3.  Secondary:   Number of Breakthrough HIV Infections   [ Time Frame: 24 months (immediate arm) and 15 months (delayed arm) ]

4.  Secondary:   Adherence to Study Drug   [ Time Frame: 24 months (immediate arm) and 15 months (delayed arm) ]

5.  Secondary:   Behavioral Safety--Unprotected Anal Sex (UAS)   [ Time Frame: Nine months ]

6.  Other Pre-specified:   >5% Bone Mineral Density Decline at Femoral Neck   [ Time Frame: 24 months (immediate arm), 15 months (delayed arm) ]

  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
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  More Information