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Safety and Acceptability Study of Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet and Rectally-Applied Tenofovir Reduced-Glycerin 1% Gel

This study has been completed.
Sponsor:
Collaborators:
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Mental Health (NIMH)
National Institutes of Health (NIH)
Information provided by (Responsible Party):
CONRAD
ClinicalTrials.gov Identifier:
NCT01687218
First received: August 27, 2012
Last updated: December 7, 2016
Last verified: December 2016
Results First Received: December 7, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Open Label
Condition: HIV
Interventions: Drug: Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)
Drug: Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)
Drug: Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)

  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
HIV-uninfected males or transgender females who were 18 years of age or older who practice receptive anal intercourse were recruited from September 2013 through November 2014 from 8 sites in Peru, Puerto Rico, South Africa, Thailand and USA.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
349 persons were screened and 154 were excluded for various reasons. The study enrolled 195 participants, 187 of whom are evaluable. Evaluable participants are those participants who were enrolled and not replaced, or were the final enrolled replacement participant for another enrolled participant who met the criteria for replacement.

Reporting Groups
  Description
Group 1

Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks); followed by Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks)

Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)

Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)

Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)

Group 2

Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks); followed by Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks)

Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)

Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)

Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)

Group 3

Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks)

Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)

Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)

Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)

Group 4

Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks); followed by Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks)

Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)

Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)

Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)

Group 5

Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks); followed by Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks)

Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)

Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)

Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)

Group 6

Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks);followed by Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks)

Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)

Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)

Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)


Participant Flow:   Overall Study
    Group 1   Group 2   Group 3   Group 4   Group 5   Group 6
STARTED   33   32   31   34   33   32 
COMPLETED   30   29   30   32   32   32 
NOT COMPLETED   3   3   1   2   1   0 
Withdrawal by Subject                2                3                0                1                1                0 
Relocated, no follow-up planned                1                0                1                1                0                0 



  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.
Includes all participants enrolled.

Reporting Groups
  Description
Group 1

Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks); followed by Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks)

Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)

Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)

Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)

Group 2

Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks); followed by Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks)

Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)

Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)

Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)

Group 3

Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks)

Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)

Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)

Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)

Group 4

Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks); followed by Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks)

Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)

Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)

Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)

Group 5

Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks); followed by Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks)

Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)

Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)

Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)

Group 6

Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks);followed by Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks)

Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)

Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)

Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)

Total Total of all reporting groups

Baseline Measures
   Group 1   Group 2   Group 3   Group 4   Group 5   Group 6   Total 
Overall Participants Analyzed 
[Units: Participants]
 33   32   31   34   33   32   195 
Age 
[Units: Years]
Mean (Standard Deviation)
 30.9  (8.5)   30.4  (10.6)   32.4  (9.2)   29.6  (8.9)   32.2  (10.6)   31.4  (7.8)   31.1  (9.3) 
Age, Customized 
[Units: Participants]
             
Under 20   2   1   2   1   2   2   10 
20-24   7   7   6   12   7   5   44 
25-29   7   11   6   6   7   6   43 
30-34   6   4   6   7   7   10   40 
35-39   6   4   2   2   2   4   20 
40-44   4   3   4   3   3   2   19 
45-49   0   0   4   2   2   3   11 
50+   1   2   1   1   3   0   8 
Gender, Customized [1] 
[Units: Participants]
             
Man   21   21   22   27   26   24   141 
Woman   0   0   1   1   1   1   4 
Transgender/Transwoman   4   6   2   3   3   1   19 
Other   5   4   6   3   3   6   27 
Refuse to answer   2   1   0   0   0   0   3 
[1] One participant from Peru did not complete a baseline CASI.
Hispanic Origin 
[Units: Participants]
             
Yes   10   9   8   8   12   8   55 
No   23   23   23   26   21   24   140 
Highest Level of Education 
[Units: Participants]
             
no schooling   0   0   0   0   0   0   0 
primary school, not complete   0   0   0   1   0   0   1 
primary school, complete   0   0   1   0   0   1   2 
secondary school, not complete   2   1   1   1   3   1   9 
secondary school, complete   2   5   6   4   4   6   27 
attended college or university   29   26   23   28   26   24   156 
Sexual Orientation (CASI) [1] 
[Units: Participants]
             
Gay/Homosexual   27   26   27   32   28   31   171 
Bisexual   3   3   3   0   3   1   13 
Straight/Heterosexual   0   1   1   1   0   0   3 
Other   1   1   0   1   2   0   5 
Refuse to answer   1   1   0   0   0   0   2 
[1] One participant from Peru did not complete a baseline CASI.
Nationality [1] 
[Units: Participants]
             
Puerto Rico   1   1   1   1   2   1   7 
Peru   7   6   6   6   7   6   38 
South Africa   3   3   3   3   3   3   18 
Thailand   9   9   9   9   9   9   54 
U.S.A.   13   13   12   15   12   13   78 
[1] Country in which the site clinic resides.
Race - Puerto Rico 
[Units: Participants]
             
White   0   0   0   0   2   0   2 
Asian   0   0   0   0   0   0   0 
Mixed   0   1   0   0   0   1   2 
Black   0   0   1   1   0   0   2 
Indigenous   0   0   0   0   0   0   0 
Other   1   0   0   0   0   0   1 
Race - Peru 
[Units: Participants]
             
White   0   0   0   1   0   0   1 
Asian   0   0   0   0   0   0   0 
Mixed   6   3   3   4   3   5   24 
Black   0   0   0   0   0   0   0 
Indigenous   1   3   3   1   4   1   13 
Other   0   0   0   0   0   0   0 
Race - South Africa 
[Units: Participants]
             
Other African tribe   0   0   0   1   0   1   2 
White   0   0   0   0   0   0   0 
Zulu   0   0   0   0   0   0   0 
Xhosa   3   2   3   2   3   1   14 
Indian   0   0   0   0   0   0   0 
Colored   0   0   0   0   0   1   1 
Other   0   1   0   0   0   0   1 
Race - Thailand 
[Units: Participants]
             
Indian   0   0   0   0   0   0   0 
Mixed   0   0   0   0   0   0   0 
Thai   9   9   9   9   9   9   54 
Chinese   0   0   0   0   0   0   0 
Other   0   0   0   0   0   0   0 
Race - U.S.A. 
[Units: Participants]
             
White   12   11   10   12   6   10   61 
Asian   0   0   0   0   2   2   4 
Mixed   0   0   0   0   2   0   2 
Black/African-American   0   0   0   3   0   0   3 
American Indian/Alaska Native   0   0   0   0   0   0   0 
Native-Hawaiian or other Pacific Islander   0   0   0   0   0   0   0 
Other   1   2   2   0   2   1   8 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Safety: Grade 2 or Higher Adverse Events   [ Time Frame: 27 weeks (three 8-week product use periods with 1-week washout periods between them) ]

2.  Primary:   Acceptability: Participant Self-report of Liking the Product. H1-Overall How do You Feel About the Product You Used Recently?   [ Time Frame: 27 weeks (three 8-week product use periods with 1-week washout periods between them) ]

3.  Primary:   Acceptability: Participant Self-report of Ease of Use. I1-Overall How Easy or Difficult Was it to Use the Product?   [ Time Frame: 27 weeks (three 8-week product use periods with 1-week washout periods between them) ]

4.  Primary:   Acceptability: Participant Self-report of Likelihood of Product Use if Shown to be Effective. N1-If This Product Provides Some Protection How Likely Would You be to Take it?   [ Time Frame: 27 weeks (three 8-week product use periods with 1-week washout periods between them) ]

5.  Secondary:   Adherence   [ Time Frame: 27 weeks (three 8-week product use periods with 1-week washout periods between them) ]

6.  Secondary:   Pharmacokinetics   [ Time Frame: 27 weeks (three 8-week product use periods with 1-week washout periods between them) ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

7.  Other Pre-specified:   Pharmacodynamics   [ Time Frame: 27 weeks (three 8-week product use periods with 1-week washout periods between them) ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

8.  Other Pre-specified:   Mucosal Immunity   [ Time Frame: 27 weeks (three 8-week product use periods with 1-week washout periods between them) ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

9.  Other Pre-specified:   Correlation Between PK and Adherence   [ Time Frame: 27 weeks (three 8-week product use periods with 1-week washout periods between them) ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

10.  Other Pre-specified:   Factors Associated With Adherence   [ Time Frame: 27 weeks (three 8-week product use periods with 1-week washout periods between them) ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

11.  Other Pre-specified:   Sexual Activity and Condom Use   [ Time Frame: 27 weeks (three 8-week product use periods with 1-week washout periods between them) ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

12.  Other Pre-specified:   Product Sharing   [ Time Frame: 27 weeks (three 8-week product use periods with 1-week washout periods between them) ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

13.  Other Pre-specified:   Problem Practices   [ Time Frame: 27 weeks (three 8-week product use periods with 1-week washout periods between them) ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  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 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: Ross D. Cranston, MD, FRCP
Organization: Division of Infectious Diseases - UPMC
phone: 412-383-2054
e-mail: rdc27@pitt.edu



Responsible Party: CONRAD
ClinicalTrials.gov Identifier: NCT01687218     History of Changes
Other Study ID Numbers: MTN-017
5UM1AI068633 ( US NIH Grant/Contract Award Number )
11857 ( Other Identifier: DAIDS protocol # )
Study First Received: August 27, 2012
Results First Received: December 7, 2016
Last Updated: December 7, 2016