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The ADAPT Study: Use of Emtricitabine and Tenofovir Disoproxil Fumarate for Pre-Exposure Prophylaxis (PrEP) (ADAPT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT01327651
First received: December 1, 2010
Last updated: March 30, 2017
Last verified: January 2017
Results First Received: January 5, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: No masking;   Primary Purpose: Prevention
Condition: HIV Infections
Intervention: Drug: Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)

  Participant Flow
  Hide 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 enrolled men, and transgender women, who have sex with men at a community clinic and clinical research site (CRS) in Bangkok, Thailand, and a CRS in Harlem in New York City, USA. Women were enrolled at a study site in Cape Town, South Africa. The last participant was enrolled in May of 2014

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 902 screened participants, 622 were eligible to be enrolled into the study, and participated in a 6-week lead-in period of directly observed dosing (DOD) of one tablet once-weekly of FTC/TDF for five observed doses followed by 1-week off drug. 86% (N=536) completed the lead-in period and were randomized to the three arms.

Reporting Groups
  Description
Daily Dosing, Cape Town Cape Town participants will receive oral FTC/TDF daily. Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
Time-driven Dosing, Cape Town

Cape Town participants will receive oral FTC/TDF twice weekly with a post-exposure dose.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Event-driven Dosing, Cape Town

Cape Town participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Daily Dosing, Bangkok Bangkok participants will receive oral FTC/TDF daily. Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
Time-driven Dosing, Bangkok

Bangkok participants will receive oral FTC/TDF twice weekly with a post-exposure dose.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors

Event-driven Dosing, Bangkok

Bangkok participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Daily Dosing, Harlem Harlem participants will receive oral FTC/TDF daily. Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
Time-driven Dosing, Harlem

Harlem participants will receive oral FTC/TDF twice weekly with a post-exposure dose.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Event-driven Dosing, Harlem

Harlem participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.


Participant Flow for 2 periods

Period 1:   Self-administered Dosing Period
    Daily Dosing, Cape Town   Time-driven Dosing, Cape Town   Event-driven Dosing, Cape Town   Daily Dosing, Bangkok   Time-driven Dosing, Bangkok   Event-driven Dosing, Bangkok   Daily Dosing, Harlem   Time-driven Dosing, Harlem   Event-driven Dosing, Harlem
STARTED [1]   60   59   60   60   59   59   59   60   60 
Week 10   59   58   60   60   59   59   57   57   56 
Week 14   59   55   57   60   58   59   54   51   54 
Week 18   57   56   56   60   57   59   53   49   53 
Week 22   59   56   55   58   56   59   50   50   51 
Week 26   58   56   53   57   56   58   50   51   49 
COMPLETED [2]   56   56   56   57   56   59   49   50   49 
NOT COMPLETED   4   3   4   3   3   0   10   10   11 
Lost to Follow-up                3                2                4                2                3                0                8                9                10 
Ineligible (retrospective result)                1                0                0                0                0                0                0                0                0 
Withdrawal by Subject                0                1                0                1                0                0                2                1                1 
[1] Week 6 (Randomization visit)
[2] Week 30

Period 2:   Post Study Follow-up
    Daily Dosing, Cape Town   Time-driven Dosing, Cape Town   Event-driven Dosing, Cape Town   Daily Dosing, Bangkok   Time-driven Dosing, Bangkok   Event-driven Dosing, Bangkok   Daily Dosing, Harlem   Time-driven Dosing, Harlem   Event-driven Dosing, Harlem
STARTED [1]   56   56   56   57   56   59   49   50   49 
COMPLETED [2]   56   55   55   57   56   59   45   49   47 
NOT COMPLETED   0   1   1   0   0   0   4   1   2 
Lost to Follow-up                0                1                1                0                0                0                4                1                2 
[1] Week 30
[2] Week 34



  Baseline Characteristics
  Hide 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.
For daily dosing arm in Cape Town, we dropped one participant from analysis, since retrospective test of HIV infection in central lab shows that this participant was seroconverted on week 6(randomization week), so she was not eligible to be randomized. Because of this, total baseline population dropped from 536 to 535.

Reporting Groups
  Description
Daily Dosing, Cape Town

Cape Town participants will receive oral FTC/TDF daily.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Time-driven Dosing, Cape Town

Cape Town participants will receive oral FTC/TDF twice weekly with a post-exposure dose.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Event-driven Dosing, Cape Town

Cape Town participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Daily Dosing, Bangkok

Bangkok participants will receive oral FTC/TDF daily.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Time-driven Dosing, Bangkok

Bangkok participants will receive oral FTC/TDF twice weekly with a post-exposure dose.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Event-driven Dosing, Bangkok

Bangkok participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Daily Dosing, Harlem

Harlem participants will receive oral FTC/TDF daily.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Time-driven Dosing, Harlem

Harlem participants will receive oral FTC/TDF twice weekly with a post-exposure dose.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Event-driven Dosing, Harlem

Harlem participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.

Total Total of all reporting groups

Baseline Measures
   Daily Dosing, Cape Town   Time-driven Dosing, Cape Town   Event-driven Dosing, Cape Town   Daily Dosing, Bangkok   Time-driven Dosing, Bangkok   Event-driven Dosing, Bangkok   Daily Dosing, Harlem   Time-driven Dosing, Harlem   Event-driven Dosing, Harlem   Total 
Overall Participants Analyzed 
[Units: Participants]
 59   59   60   60   59   59   59   60   60   535 
Age 
[Units: Years]
Median (Inter-Quartile Range)
 25 
 (21 to 37) 
 26 
 (21 to 33) 
 25 
 (21 to 37) 
 31 
 (28 to 34) 
 28 
 (25 to 35) 
 31 
 (27 to 34) 
 28 
 (23 to 43) 
 31 
 (24 to 41) 
 32 
 (24 to 46) 
 29 
 (24 to 37) 
Age, Customized 
[Units: Participants]
Count of Participants
                   
18-24 years   26   24   26   8   12   8   19   17   17   157 
25-29 years   14   15   8   13   19   16   13   11   8   117 
30-39 years   10   11   16   36   23   28   11   12   14   161 
40+ years   9   9   10   3   5   7   16   20   21   100 
Sex/Gender, Customized 
[Units: Participants]
Count of Participants
                   
Female   59   59   60   0   0   0   0   0   0   178 
Male   0   0   0   59   58   59   57   59   58   350 
Transgender woman   0   0   0   1   1   0   2   0   1   5 
Gender queer   0   0   0   0   0   0   0   1   1   2 
Education 
[Units: Participants]
Count of Participants
                   
Less than secondary      38  64.4%      39  66.1%      39  65.0%      0   0.0%      1   1.7%      1   1.7%      16  27.1%      18  30.0%      7  11.7%      159  29.7% 
Secondary and above      21  35.6%      20  33.9%      21  35.0%      60 100.0%      58  98.3%      58  98.3%      43  72.9%      42  70.0%      53  88.3%      376  70.3% 
Number of sex partners in the past 3 months [1] 
[Units: Sex partners]
Median (Inter-Quartile Range)
 1 
 (1 to 1) 
 1 
 (1 to 1) 
 1 
 (1 to 1) 
 3 
 (2 to 10) 
 3 
 (1 to 10) 
 3 
 (2 to 5) 
 3 
 (2 to 5) 
 3 
 (2 to 6) 
 4 
 (2 to 7) 
 2 
 (1 to 5) 
[1] Median number of sex partners in the past 3 months, measured at baseline
Number of anal intercourse without a condom 
[Units: Anal intercourse]
Median (Inter-Quartile Range)
 2 
 (0 to 7) 
 2 
 (0 to 5) 
 1 
 (0 to 4) 
 0 
 (0 to 5) 
 0 
 (0 to 3) 
 0 
 (0 to 0) 
 3 
 (0 to 5) 
 3 
 (1 to 10) 
 5 
 (1 to 9) 
 1 
 (0 to 5) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Proportion of Sexual Exposures Covered by Pre- and Post-exposure Dosing   [ Time Frame: From week 6 (randomization week) to week 30 (end of self-administered dosing) ]

2.  Primary:   The (Minimum) Total Number of Pills Needed for 100% Coverage Over the Follow-up Period (Based on Randomization Arm and Self-reported Sexual History in the Weekly Interviews)   [ Time Frame: From week 6 (randomization week) to week 30 (end of self-administered dosing) ]

3.  Primary:   The Total Pills Actually Used Over the Follow-up Period   [ Time Frame: From week 6 (randomization week) to week 30 (end of self-administered dosing) ]

4.  Primary:   Self-reported Side Effect or Symptom Scores   [ Time Frame: From week 6 (randomization week) to week 30 (end of self-administered dosing) ]

5.  Secondary:   Measurement of TFV-DP (Tenofovir Diphosphate) in PBMC (Peripheral Blood Mononuclear Cell)   [ Time Frame: week 10, 18 and 30, which is 4 weeks, 12 weeks, and 24 weeks after randomization ]

6.  Secondary:   A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm   [ Time Frame: From week 6 (randomization week) to week 30 (end of self-administered dosing) ]

7.  Secondary:   A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study   [ Time Frame: From enrollment to week 30 (end of self-administered dosing) ]

8.  Secondary:   The Percentage of Correctly Timed Adherence (Number of Pills Taken Within the Recommended Time Frame/Number of Pills Recommended) During 24 Weeks of Follow-up Based on Weekly Interviews and Adjusted EDM (Electronic Drug Monitoring) Data   [ Time Frame: From week 6 (randomization week) to week 30 (end of self-administered dosing) ]

9.  Secondary:   The Proportion of Participants Who Discontinue All PrEP Use Based on Self-report Via CASI or Weekly Interviews   [ Time Frame: From Week 6 to Week 30 ]

10.  Secondary:   A Listing of Adverse Events (AEs) by Grade, Relationship to Study Product, and Arm   [ Time Frame: From week 6 (randomization week) to week 30 (end of self-administered dosing) ]

11.  Secondary:   A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study   [ Time Frame: From Enrollment to week 30 (end of self-administered dosing) ]

12.  Secondary:   A Listing, by Arm, of Drug Resistance Test Results and Plasma HIV RNA Levels Among All Participants Who Seroconvert While on Study   [ Time Frame: From Enrollment to week 30 (end of self-administered dosing) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
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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.


Results Point of Contact:  
Name/Title: Maoji Li (Statistical Research Associate)
Organization: Fred Hutchinson Cancer Research Center
phone: 2066676035
e-mail: mli2@fredhutch.org


Publications:

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT01327651     History of Changes
Other Study ID Numbers: HPTN 067 (ADAPT)
10852 ( Registry Identifier: DAIDS-ES )
Study First Received: December 1, 2010
Results First Received: January 5, 2017
Last Updated: March 30, 2017