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Trial record 1 of 1 for:    NCT01505114
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Evaluating the Safety and Tolerability of Antiretroviral Drug Regimens Used as Pre-Exposure Prophylaxis to Prevent HIV Infection in At-Risk Men Who Have Sex With Men and in At-Risk Women

This study has been completed.
Sponsor:
Collaborators:
HIV Prevention Trials Network
AIDS Clinical Trials Group
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT01505114
First received: January 4, 2012
Last updated: June 20, 2017
Last verified: June 2017
Results First Received: May 16, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Prevention
Condition: HIV Infection
Interventions: Drug: Maraviroc
Drug: Emtricitabine
Drug: Tenofovir disoproxil fumarate
Other: Maraviroc placebo
Other: Emtricitabine placebo
Other: Tenofovir disoproxil fumarate placebo

  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 started the enrollment in June 2012. Accrual will occur in a staggered fashion, with men beginning first and women beginning several months later. Accrual for the men will occur over approximately 9 months, and accrual for the women will require approximately 9 months.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Exclusion--reactive HIV test results;Co-enrollment in any other HIV interventional research study; Use of ARV therapy; Prior history of any procedure altering the gastrointestinal tract or drug absorption; Receipt of prohibited medications; Known allergy to soy/peanuts; Weight>300 lbs;

Reporting Groups
  Description
MVC Only

MVC 300 mg plus FTC placebo and TDF placebo orally once daily

Maraviroc: 300-mg tablet, once daily, from Week 0 through Week 48

Emtricitabine placebo: Once daily from Week 0 through Week 48

Tenofovir disoproxil fumarate placebo: Once daily from Week 0 through Week 48

MVC + FTC

MVC 300 mg plus FTC 200 mg and TDF placebo orally once daily

Maraviroc: 300-mg tablet, once daily, from Week 0 through Week 48

Emtricitabine: 200-mg capsule, once daily, from Week 0 through Week 48

Tenofovir disoproxil fumarate placebo: Once daily from Week 0 through Week 48

MVC + TDF

MVC 300 mg plus FTC placebo and TDF 300 mg orally once daily

Maraviroc: 300-mg tablet, once daily, from Week 0 through Week 48

Tenofovir disoproxil fumarate: 300-mg tablet, once daily, from Week 0 through Week 48

Emtricitabine placebo: Once daily from Week 0 through Week 48

TDF + FTC

MVC placebo plus FTC 200 mg and TDF 300 mg orally once daily

Emtricitabine: 200-mg capsule, once daily, from Week 0 through Week 48

Tenofovir disoproxil fumarate: 300-mg tablet, once daily, from Week 0 through Week 48

Maraviroc placebo: Once daily from Week 0 through Week 48


Participant Flow:   Overall Study
    MVC Only   MVC + FTC   MVC + TDF   TDF + FTC
STARTED   148   148   147   151 
COMPLETED   123   135   129   128 
NOT COMPLETED   25   13   18   23 
Withdrawal by Subject                5                4                4                7 
Death                1                0                0                1 
unable to adhere to visit schedule                3                2                3                3 
Lost to Follow-up                11                5                8                7 
relocated                4                2                2                3 
inadvertent enrollment due to peanut all                0                0                0                1 
staff safety concerns                0                0                0                1 
investigator decision                1                0                1                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.
No text entered.

Reporting Groups
  Description
Arm 1

MVC 300 mg plus FTC placebo and TDF placebo orally once daily

Maraviroc: 300-mg tablet, once daily, from Week 0 through Week 48

Emtricitabine placebo: Once daily from Week 0 through Week 48

Tenofovir disoproxil fumarate placebo: Once daily from Week 0 through Week 48

Arm 2

MVC 300 mg plus FTC 200 mg and TDF placebo orally once daily

Maraviroc: 300-mg tablet, once daily, from Week 0 through Week 48

Emtricitabine: 200-mg capsule, once daily, from Week 0 through Week 48

Tenofovir disoproxil fumarate placebo: Once daily from Week 0 through Week 48

Arm 3

MVC 300 mg plus FTC placebo and TDF 300 mg orally once daily

Maraviroc: 300-mg tablet, once daily, from Week 0 through Week 48

Tenofovir disoproxil fumarate: 300-mg tablet, once daily, from Week 0 through Week 48

Emtricitabine placebo: Once daily from Week 0 through Week 48

Arm 4

MVC placebo plus FTC 200 mg and TDF 300 mg orally once daily

Emtricitabine: 200-mg capsule, once daily, from Week 0 through Week 48

Tenofovir disoproxil fumarate: 300-mg tablet, once daily, from Week 0 through Week 48

Maraviroc placebo: Once daily from Week 0 through Week 48

Total Total of all reporting groups

Baseline Measures
   Arm 1   Arm 2   Arm 3   Arm 4   Total 
Overall Participants Analyzed 
[Units: Participants]
 147   151   148   148   594 
Age [1] 
[Units: Years]
Median (Full Range)
         
Participants Analyzed 
[Units: Participants]
 101   106   99   100   406 
   30 
 (18 to 65) 
 29.5 
 (18 to 62) 
 30 
 (18 to 70) 
 31 
 (18 to 60) 
 30 
 (18 to 70) 
[1] analysis for men
Age [1] 
[Units: Years]
Median (Full Range)
         
Women           
Participants Analyzed 
[Units: Participants]
 46   45   49   48   188 
Women   40 
 (18 to 61) 
 36 
 (19 to 57) 
 37 
 (22 to 60) 
 37 
 (18 to 60) 
 36 
 (18 to 61) 
[1] Analysis for women
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Participants Analyzed 
[Units: Participants]
 147   151   148   148   594 
Female      46  31.3%      45  29.8%      49  33.1%      48  32.4%      188  31.6% 
Male      101  68.7%      106  70.2%      99  66.9%      100  67.6%      406  68.4% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
         
American Indian/Alaskan Native           
Participants Analyzed 
[Units: Participants]
 147   151   148   148   594 
American Indian/Alaskan Native   4   6   2   5   17 
Asian           
Participants Analyzed 
[Units: Participants]
 147   151   148   148   594 
Asian   6   1   5   5   17 
Black or African           
Participants Analyzed 
[Units: Participants]
 147   151   148   148   594 
Black or African   61   64   62   51   238 
Native Hawaiian or Pacific Islander           
Participants Analyzed 
[Units: Participants]
 147   151   148   148   594 
Native Hawaiian or Pacific Islander   1   2   1   3   7 
White           
Participants Analyzed 
[Units: Participants]
 147   151   148   148   594 
White   73   80   72   78   303 
Other           
Participants Analyzed 
[Units: Participants]
 147   151   148   148   594 
Other   15   14   10   16   55 
education 
[Units: Participants]
Count of Participants
         
8th Grade or Less           
Participants Analyzed 
[Units: Participants]
 147   151   148   148   594 
8th Grade or Less   1   3   0   1   5 
Some High School           
Participants Analyzed 
[Units: Participants]
 147   151   148   148   594 
Some High School   10   7   6   9   32 
High School Graduate or Equivalent           
Participants Analyzed 
[Units: Participants]
 147   151   148   148   594 
High School Graduate or Equivalent   35   27   25   27   114 
Vocational/Trade/Technical School           
Participants Analyzed 
[Units: Participants]
 147   151   148   148   594 
Vocational/Trade/Technical School   3   7   7   6   23 
Some College or 2 Year Degree           
Participants Analyzed 
[Units: Participants]
 147   151   148   148   594 
Some College or 2 Year Degree   51   43   57   55   206 
Finished College           
Participants Analyzed 
[Units: Participants]
 147   151   148   148   594 
Finished College   37   40   36   40   153 
masters or other advanced degree           
Participants Analyzed 
[Units: Participants]
 147   151   148   148   594 
masters or other advanced degree   10   24   17   10   61 
Marital Status 
[Units: Participants]
Count of Participants
         
Married/Civil Union/Legal Partnership           
Participants Analyzed 
[Units: Participants]
 147   151   148   148   594 
Married/Civil Union/Legal Partnership   8   9   7   14   38 
Living with Primary Partner           
Participants Analyzed 
[Units: Participants]
 147   151   148   148   594 
Living with Primary Partner   25   21   25   21   92 
Not Living with Primary Partner           
Participants Analyzed 
[Units: Participants]
 147   151   148   148   594 
Not Living with Primary Partner   12   17   19   14   62 
Single/Divorced/Widowed           
Participants Analyzed 
[Units: Participants]
 147   151   148   148   594 
Single/Divorced/Widowed   102   103   96   98   399 
Other           
Participants Analyzed 
[Units: Participants]
 147   151   148   148   594 
Other   0   1   1   1   3 
Employment Status 
[Units: Participants]
Count of Participants
         
Full-time Employment           
Participants Analyzed 
[Units: Participants]
 147   151   148   148   594 
Full-time Employment   56   68   59   74   257 
Part-time Employment           
Participants Analyzed 
[Units: Participants]
 147   151   148   148   594 
Part-time Employment   38   35   36   25   134 
Not Employed           
Participants Analyzed 
[Units: Participants]
 147   151   148   148   594 
Not Employed   53   48   52   49   202 


  Outcome Measures

1.  Primary:   Occurrence of Grade 3 or Higher Adverse Events (AEs)   [ Time Frame: Through Week 48 ]


  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: Chunyuan Wu
Organization: Fred Hutchinson cancer Research center
phone: 206-667-5567
e-mail: cwu@scharp.org


Publications:

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT01505114     History of Changes
Other Study ID Numbers: HPTN 069/A5305 (NEXT Prep)
11789 ( Registry Identifier: DAIDS-ES )
HPTN 069/A5305
HPTN 069
HPTN 069/NEXT Prep
Study First Received: January 4, 2012
Results First Received: May 16, 2017
Last Updated: June 20, 2017