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A Demonstration Project to Add Pre- or Post-exposure Prophylaxis to Combination HIV Prevention Services (PATH-PrEP)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01781806
First Posted: February 1, 2013
Last Update Posted: September 20, 2017
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.
Collaborators:
Los Angeles County Department of Public Health
Los Angeles LGBT Center
The OASIS Clinic
AIDS Project Los Angeles
Information provided by (Responsible Party):
Dr. Raphael Landovitz, University of California, Los Angeles
Results First Submitted: August 24, 2017  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition: HIV Prevention
Intervention: Drug: emtricitabine 200mg/tenofovir 300mg

  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
No text entered.

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
Cohort H (PrEP)

Participants in the H cohort will be provided with a CPP (customized prevention package) including daily Truvada-based PrEP(Pre-Exposure Prophylaxis).

High Risk Cohort Criteria (one or more of the following has to be met):

  1. No condom use during anal intercourse with ≥3 male sex partners who are HIV-positive or of unknown HIV status during the last three months.
  2. STI diagnosis during the last 12 months.
  3. Previous PEP use during the last 12 months (* see exclusion criteria)
  4. Has at least one HIV infected sexual partner for ≥4 weeks.

emtricitabine 200mg/tenofovir 300mg: The intervention medication will be tenofovir + emtricitabine, provided as a fixed-dose combination tablet as Truvada®. Dosing is 1 tablet by mouth once daily. For participants with a a confirmed (i.e. two consecutive) reduction in CrCl to <50 mL/min, Truvada will be dose-reduced to 1 tablet by mouth every other day. For patients with creatinine clearance <30 mL/min, Truvada will be discontinued.

Cohort LM (PEP)

Participants who do not meet criteria for High Risk (Cohort H) will be assigned to the LM (low moderate) cohort and will receive a customized prevention package based on baseline assessments (in the same manner as the Cohort H Participants). In addition, they will receive education on the availability and use of post-exposure prophylaxis.

emtricitabine 200mg/tenofovir 300mg: The intervention medication will be tenofovir + emtricitabine, provided as a fixed-dose combination tablet as Truvada®. Dosing is 1 tablet by mouth once daily. For participants with a a confirmed (i.e. two consecutive) reduction in CrCl to <50 mL/min, Truvada will be dose-reduced to 1 tablet by mouth every other day. For patients with creatinine clearance <30 mL/min, Truvada will be discontinued.


Participant Flow:   Overall Study
    Cohort H (PrEP)   Cohort LM (PEP)
STARTED   297   4 
Week 4 Visit   284   4 
Week 8 Visit   277   4 
Week 12 Visit   273   2 
Week 24 Visit   259   1 
Week 36 Visit   247   1 
COMPLETED [1]   222   1 
NOT COMPLETED   75   3 
[1] (Week 48 Visit)



  Baseline Characteristics
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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
Cohort H (PrEP)

Participants in the H cohort will be provided with a CPP (customized prevention package) including daily Truvada-based PrEP(Pre-Exposure Prophylaxis).

High Risk Cohort Criteria (one or more of the following has to be met):

  1. No condom use during anal intercourse with ≥3 male sex partners who are HIV-positive or of unknown HIV status during the last three months.
  2. STI diagnosis during the last 12 months.
  3. Previous PEP use during the last 12 months (* see exclusion criteria)
  4. Has at least one HIV infected sexual partner for ≥4 weeks.

emtricitabine 200mg/tenofovir 300mg: The intervention medication will be tenofovir + emtricitabine, provided as a fixed-dose combination tablet as Truvada®. Dosing is 1 tablet by mouth once daily. For participants with a a confirmed (i.e. two consecutive) reduction in CrCl to <50 mL/min, Truvada will be dose-reduced to 1 tablet by mouth every other day. For patients with creatinine clearance <30 mL/min, Truvada will be discontinued.

Cohort LM (PEP)

Participants who do not meet criteria for High Risk (Cohort H) will be assigned to the LM (low moderate) cohort and will receive a customized prevention package based on baseline assessments (in the same manner as the Cohort H Participants). In addition, they will receive education on the availability and use of post-exposure prophylaxis.

emtricitabine 200mg/tenofovir 300mg: The intervention medication will be tenofovir + emtricitabine, provided as a fixed-dose combination tablet as Truvada®. Dosing is 1 tablet by mouth once daily. For participants with a a confirmed (i.e. two consecutive) reduction in CrCl to <50 mL/min, Truvada will be dose-reduced to 1 tablet by mouth every other day. For patients with creatinine clearance <30 mL/min, Truvada will be discontinued.

Total Total of all reporting groups

Baseline Measures
   Cohort H (PrEP)   Cohort LM (PEP)   Total 
Overall Participants Analyzed 
[Units: Participants]
 297   4   301 
Age 
[Units: Years]
Median (Inter-Quartile Range)
 33 
 (28 to 42) 
 35 
 (32 to 39) 
 34 
 (28 to 42) 
Sex/Gender, Customized 
[Units: Participants]
Count of Participants
     
Male       
Male      296  99.7%      4 100.0%      300  99.7% 
Transgender      1   0.3%      0   0.0%      1   0.3% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
Non-Hispanic White   150   1   151 
Non-Hispanic Black   30   0   30 
Hispanic/Latino   82   1   83 
Asian   14   1   15 
Pacific Islander/Alaskan Native   4   0   4 
Mixed Race/Other   16   1   17 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States   297   4   301 
Education 
[Units: Participants]
Count of Participants
     
High school or less      33  11.1%      0   0.0%      33  11.0% 
Some college      105  35.4%      1  25.0%      106  35.2% 
College graduate      104  35.0%      2  50.0%      106  35.2% 
Any postgraduate      55  18.5%      1  25.0%      56  18.6% 
Insurance 
[Units: Participants]
Count of Participants
     
Uninsured      91  30.6%      2  50.0%      93  30.9% 
Insured      200  67.3%      1  25.0%      201  66.8% 
Unknown      6   2.0%      1  25.0%      7   2.3% 
Marital Status 
[Units: Participants]
Count of Participants
     
Married/civil union/legal partnership      9   3.0%      0   0.0%      9   3.0% 
Living with primary or main partner      42  14.1%      0   0.0%      42  14.0% 
Have primary or main partner, not living together      39  13.1%      0   0.0%      39  13.0% 
Single/divorced/widowed      194  65.3%      4 100.0%      198  65.8% 
Other      12   4.0%      0   0.0%      12   4.0% 
Unknown      1   0.3%      0   0.0%      1   0.3% 
Family Income 
[Units: Participants]
Count of Participants
     
$20,000 or less   92   0   92 
$20,001 - $50,000   111   3   114 
$50,001 or more   94   1   95 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Safety: Adverse Events/Serious Adverse Events   [ Time Frame: Baseline to 48 weeks ]

2.  Other Pre-specified:   HIV Seroconversion and Treatment-emergent Resistance   [ Time Frame: Baseline to 48 weeks ]

3.  Secondary:   Adherence to Daily FTC/Tenofovir   [ Time Frame: Baseline to 48 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

4.  Other Pre-specified:   Change in Transmission-risk Behavior   [ Time Frame: Baseline to 48 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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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: Dr. Raphael J. Landovitz
Organization: UCLA CARE Center
phone: (310) 825-6689
e-mail: rlandovitz@mednet.ucla.edu



Responsible Party: Dr. Raphael Landovitz, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01781806     History of Changes
Other Study ID Numbers: EI11-LA-002
First Submitted: January 29, 2013
First Posted: February 1, 2013
Results First Submitted: August 24, 2017
Results First Posted: September 20, 2017
Last Update Posted: September 20, 2017