HPTN 069: Evaluating the Safety and Tolerability of Antiretroviral Drug Regimens Used as Pre-Exposure Prophylaxis to Prevent HIV Infection in At-Risk Men and Women

Study Status

Open to Enrollment

Study Description

This clinical trial is for HIV-negative men and women who may be at risk of becoming infected with HIV.

Pre-exposure prophylaxis (PrEP) is a promising strategy of using HIV medications to prevent HIV transmission in HIV-negative people who are at high risk of becoming infected with HIV. This study will evaluate the safety and tolerability of 4 antiretroviral (ARV) regimens in preventing HIV in men who have sex with men and transgender women.

The antiretroviral drugs used in the study are maraviroc, emtricitabine and tenofovir and are all taken as pills. They are FDA-approved to treat HIV infection but are not approved for PrEP.  The study will help determine if these drugs are safe to take in people who are not HIV-positive, and the study will also evaluate how well HIV-negative people tolerate taking the drugs.

Study participants will be randomly assigned to one of four study groups:

  • Group 1: Maraviroc + placebo + placebo (a placebo is a blank pill that looks like medication but contains no actual medicine)
  • Group 2: Maraviroc + emmtricitabine + placebo
  • Group 3: Maraviroc + tenofovir + placebo
  • Group 4: Tenofovir + emtricitabine + placebo 
Neither you nor the study staff will know which group or drugs you are taking until about 6 months after the study ends. Participation in the study will last approximately 49 weeks.

Study participants will receive:

  • Free, rapid HIV testing (results available in 20 minutes)
  • Risk reduction counseling
  • Free testing for Hepatitis B at screening visit
  • Exams, lab tests and all study drugs provided at no cost
  • Compensation for their time at each scheduled study visit

Click here to read Frequently Asked Questions about the HPTN 069 PrEP study.

 For the convenience of our study participants, we have 2 locations:

Chelsea: 119 West 24th Street
Upper East Side/East 68th Street: Baker 24 at NewYork-Presbyterian/Weill Cornell Medical Center
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Disease Status and/or Stage

HIV-Negative, At-Risk Men Who Have Sex with Men and At-Risk Women

Sponsor

NIAID

Key Eligibility

  • Men, women and transgender women (born male) age 18 and older
  • HIV-negative
  • Sexually active with men within the past 3 months
  • Have not taken antiretroviral medications (for PEP or PrEP) in the last 3 months before entering the study
  • Detailed eligibility reviewed when you contact the study team

Principal Investigator

Roy Gulick, MD

Contact

Protocol ID

HPTN 069

Healthy Volunteers

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Contact Us

For general inquiries, or if you need assistance finding a study, please contact:

Erica Bersin
Tel: (646) 962-8232
[email protected]

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