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MTN-035 is a multi-site, randomized-sequence, 1:1:1:1:1:1, three-period, open-label crossover study. The study will evaluate the safety, acceptability and tolerability of and adherence to three placebo dosage forms (insert, douche, suppository) when each is applied rectally and used prior to RAI over a 4-week-long period. The study population will consist of healthy, HIV-uninfected men (cisgender and transgender) and transgender women (TGW) who are 18-35 years of age and who report engaging in RAI. Participants will be randomized equally across six application sequences which determine the order each dosage form will be used. Each dosage form will be used for approximately four weeks, and there will be a 1-week washout period between each dosage form application period.

 

It is hypothesized that the placebo rectal insert, the placebo rectal douche, and the placebo rectal suppository will be safe acceptable and tolerable to participants, and that adherence will be high. It is anticipated that this study will take approximately 9-12 months to enroll the target sample size, and each participant will be followed up for approximately 3.5 months. It is also anticipated that sites in the US will be activated to enroll participants in Q1 2019, while international sites will be activated in Q2 2019.

Protocol Chair(s)
Bauermeister, Jose (Protocol Chair)
Protocol Title
Acceptability, Tolerability, and Adherence of Three Rectal Microbicide Placebo Formulations among HIV Seronegative Cisgender Men, Transgender Men and Transgender Women Who Engage in Receptive Anal Intercourse
DAIDS Protocol ID
38459
Status
Enrolling
Formulation
Douche
Rectal Insert
Rectal Suppository
Drug
Placebo
Study Focus/Product Administration
Rectal
Study Type
Behavioral
Safety
Countries
Malawi
Peru
South Africa
Thailand
United States
Population
Men (cisgender men, non‐transgender men)   
Transgender men
Transgender women
Funder(s)
Division of AIDS, US National Institute of Allergy and Infectious Diseases
US Eunice Kennedy Shriver National Institute of Child Health and Human Development
US National Institute of Mental Health
US National Institutes of Health