Pre-Exposure Prophylaxis and Timed Intercourse for HIV-Discordant Couples (PrEP-HIVD)
Status:Withdrawn
Phase:Open Label
Principal Investigator(s):Danny J Schust, M.D
Objective:The investigators propose to enroll HIV-discordant couples who have been counseled on the safer alternatives of donor insemination, adoption and remaining childless; have been offered referral to a clinic offering sperm washing with insemination or in vitro fertilization (IVF); have been apprised of the risks of using PrEP and one timed intercourse per cycle; and decide to proceed with this method. Couples will be from the population of HIV-discordant patients with a minimal risk of disease transmission as described above. After evaluation for normal fertility and low potential for disease transmission, the couple will receive instruction on timing of the most fertile day of the cycle, and the woman will be given a prescription for the PrEP medication. The woman and any offspring will be followed for 6 months using blood tests to check for evidence of HIV infection.
Prevention Option(s):PrEP
Study Design:Open label
Arms and Assigned Interventions
DescriptionA couple in which the man is HIV-seropositive and the woman is HIV-seronegative who wish to have a biologically related child. Couple will use condoms for all sexual acts except one act of unprotected intercourse during the fertile period when the woman will be taking the drug Truvada.
Mode of Delivery
ARMs
Official Code:
NCT02572505
Trial Sponsors:
University of Missouri-Columbia
Start Date
End Date
November 1, 2015
October 1, 2020
Enrollment:50
Age range:
18 Years ↔
40 Years
Population:Cisgender Men, Cisgender Women