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(MMA-0930) A Phase 3, Randomized, Double-blind Study to Evaluate the Safety and Efficacy of Emtricitabine and Tenofovir Alafenamide (F/TAF) Fixed-Dose Combination Once Daily for Pre-Exposure Prophylaxis in Men and Transgender Women Who Have Sex with Men a


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A Phase 3, Randomized, Double-blind Study to Evaluate the Safety and Efficacy of Emtricitabine and Tenofovir Alafenamide (F/TAF) Fixed-Dose Combination Once Daily for Pre-Exposure Prophylaxis in Men and Transgender Women Who Have Sex with Men and Are at Risk of HIV-1 Infection

Principal Investigator:
Martin H. Markowitz M.D.

Investigators:

Contact Information:
Recruitment Specialist
1230 York Avenue
New York , NY 10065
Telephone: 1800RUCARES
Enrollment Status:
Closed to Enrollment

Brief Summary of Protocol:
This study will test an experimental drug named Emtricitabine and Tenofovir Alafenamide (F/TAF) fixed-dose combination for the prevention of HIV-1 infection, also known as Pre Exposure Prophylaxis (PrEP). The experimental drug being evaluated in this study is one pill containing both emtricitabine (F) and tenofovir alafenamide (TAF). You will receive either the experimental PrEP drug (F/TAF) or Truvada® (F/TDF). Both Truvada and F/TAF are FDA approved for use as part of chronic HIV treatment. Only Truvada is approved for use (United States and Canada) as PrEP. Truvada is a fixed-dose combination of emtricitabine (F) and tenofovir disoproxil fumarate (TDF) and is very similar to F/TAF. PrEP medication is used by people who have a high risk for HIV infection. Daily use of Truvada for PrEP helps to lower the chances of getting infected from a sexual partner who is HIV positive. This study is testing F/TAF for PrEP as a possible option for people with a high sexual risk of HIV-1 infection. From the protocol Based on available data, the use of F/TAF for PrEP would provide a new option for persons with high sexual risk of HIV-1 acquisition. Based on data with F/TAF based regimens used for treatment of chronic HIV-1 infection, the improved safety profile of F/TAF (relative to F/TDF) reduces the risk of a negative impact on bone mineralization in younger adults (18-25 years of age) who are still in a bone growth phase, and also reduces the risk of a negative impact on renal function in older adults with risk factors for chronic kidney disease. Use of F/TAF once daily for PrEP is expected to be similarly efficacious to Truvada but also have an improved safety profile. There is considerable data demonstrating that F/TAF (administered as either Genvoya or as F/TAF + a third agent) has statistically significant improvement in both renal and bone safety profiles in both treatment-naïve patients and in virologically suppressed patients who switch from a TDF based regimen (Refer to the Genvoya Prescribing Information for more details). These improvements in measures of renal and bone safety, most notably no reported cases of proximal renal tubulopathy (including Fanconi Syndrome), are most likely due to the 90% reduction in plasma TFV levels observed in subjects receiving TAF-based regimens. The use of F/TAF for PrEP to reduce the risk of sexually acquired HIV-1 in uninfected individuals at high risk may provide an effective prevention regimen with a significantly improved renal and bone safety profile relative to Truvada. This is of particular importance for HIV-1 negative persons who are otherwise likely to be healthy, in whom the acceptability of medication related risks relative to benefit must be weighed carefully. The present study will be conducted in MSM and TGW who are at least 18 years of age, a population consistently at highest risk of HIV-1 acquisition through sexual behavior.



Detailed Description of Protocol:




What specifically makes a person eligible for the study?
You may be eligible to enter this study:

• At least 18 years of age
• HIV negative


Gender:
Male

Age(s):
At least 18

Children permitted to participate:
No

Potential Benefits.....
You will not receive any direct medical benefit from taking part in this study. The potential benefit to society may be information gained on the safety and effectiveness of the study drug for patients in the future.



Compensation:
Compensation is provided