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Status
Ongoing
Phase
Open Label
Objective
MTN-035, or DESIRE (Developing and Evaluating Short-acting Innovations for Rectal Use), is an open label crossover study to systematically examine three methods for delivering drugs to help prevent HIV infection from anal sex.
Last updated May 9, 2021
Prevention Option(s)
Microbicides
Study Design
Randomized
Double-blind
Arms and Assigned Interventions
Description
Placebo Comparator: Product Sequence A
Participants will use rectal inserts during the first 4-week product use period, rectal douches during the second 4-week product use period, and rectal suppositories during the third and final 4-week product use period.
ARMs
Placebo Comparator
Description
Placebo Comparator: Product Sequence B
Participants will use rectal douches during the first 4-week product use period, rectal suppositories during the second 4-week product use period, and rectal inserts during the third and final 4-week product use period.
ARMs
Placebo Comparator
Description
Placebo Comparator: Product Sequence C
Participants will use rectal suppositories during the first 4-week product use period, rectal inserts during the second 4-week product use period, and rectal douches during the third and final 4-week product use period.
ARMs
Placebo Comparator
Description
Placebo Comparator: Product Sequence D
Participants will use rectal inserts during the first 4-week product use period, rectal suppositories during the second 4-week product use period, and rectal douches during the third and final 4-week product use period.
ARMs
Placebo Comparator
Description
Placebo Comparator: Product Sequence E
Participants will use rectal douches during the first 4-week product use period, rectal inserts during the second 4-week product use period, and rectal suppositories during the third and final 4-week product use period.
ARMs
Placebo Comparator
Description
Placebo Comparator: Product Sequence F
Participants will use rectal suppositories during the first 4-week product use period, rectal douches during the second 4-week product use period, and rectal inserts during the third and final 4-week product use period.
ARMs
Placebo Comparator
Official Code
Trial Sponsors
NIAID (DAIDS-ES: 38459)
April 2019
July 2020
Enrollment
217
18
Years
35
Population
Men
Transgender men
Transgender women
Sites
Blantyre CRS
Malawi
San Miguel Clinical Research Site
Lima
Peru
WRHI CRS
South Africa
Chiang Mai University AIDS Prevention
Chiang Mai
Thailand
Alabama Microbicide CRS
Birmingham, Alabama
United States of America
Bridge HIV CRS
San Francisco, California
United States of America
University of Pittsburgh CRS
Pittsburgh, Pennsylvania
United States of America