NextPrEP: A Research Study for Women
Study: CTRC: HPTN 069 - A Phase II Randomized, Double-Blind, Study of the Safety and Tolerability of Maraviroc (MVC), Maraviroc + Emtricitabine (MVC+FTC), Maraviroc + Tenofovir disoproxil fumarate (MVC+TDF), or Tenofovir disoproxil fumarate + Emtricitabine (TDF+FTC) For Pre-Exposure Prophylaxis (PrEP) To Prevent HIV Transmission in At-Risk Men Who Have Sex with Men and in At-Risk Women
Study Purpose: The purpose of this study is to evaluate 2-3 HIV medicines in at-risk HIV negative women, to see if the medicines are safe and tolerable, meaning do they make you feel sick or have side effects. The medicines are approved for people who are HIV positive, and we want to see if they are also safe for those that are HIV negative. In the future, the meds may be used to help prevent HIV transmission, but in this study we are not giving the study drugs for prevention, so we recommend you to still protect yourself by using condoms throughout the study.
There is also a part of the study that involves collecting tissue samples, or biopsies. The medications are not only found in your blood, but in other body tissues. We will ask to test your blood, hair, vaginal fluid, and cervical tissues. You will not be put into contact with the HIV virus in any way by participating in the biopsies.
Eligibility: You should not be in this study if you are allergic to soy or peanuts. If you are a woman and are pregnant, you are not eligible to be in this study.
1. There will be 11 visits at the hospital clinic over 1 year.
2. We will ask your permission for a trained study team member (physician or physician assistant) to collect 2 small pieces (biopsies) of your cervix and collect vaginal fluid at four study visits.
3. We will also request a small sample of your hair at 4 study visits.
4. At each visit, you will need to have some of your blood drawn by a trained phlebotomist.
5. You will be asked to take 3 pills once a day.
6. You will not be charged for the medications, the lab work, or the procedures required by the study.
Duration: Each person will be in the study for about a year.
Compensation: Up to $1,935 for completion of ALL study visits
Contact: Donna Pittard, RN, (919) 843-6512, email@example.com
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