Pre-Exposure Prophylaxis and Timed Intercourse for HIV-Discordant Couples (PrEP-HIVD)
|ClinicalTrials.gov Identifier: NCT02572505|
Recruitment Status : Withdrawn
First Posted : October 9, 2015
Last Update Posted : October 6, 2017
|Condition or disease||Intervention/treatment||Phase|
|HIV Infertility||Drug: Truvada||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pre-Exposure Prophylaxis and Timed Intercourse for HIV-Discordant Couples|
|Actual Study Start Date :||November 2015|
|Actual Primary Completion Date :||September 20, 2017|
|Actual Study Completion Date :||September 20, 2017|
Experimental: HIV-Discordant Couple
A 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.
Female patient will take Truvada and use condoms for each act of intercourse except once at the optimal time for fertility.
- Proportion of women remaining HIV-seronegative for 6 months after a treatment menstrual cycle [ Time Frame: 6 months after each menstrual cycle in which HIV-discordant couple has one act of unprotected intercourse ]After having one act of unprotected intercourse at the woman's fertile period, she will be tested at 6 months by HIV Ab test. Outcome will be reported as proportion of women becoming HIV-seropositive after one cycle of treatment. It is expected that this will be zero.
- Proportion of couples achieving pregnancy after each treatment menstrual cycle. [ Time Frame: Approximately one month after unprotected intercourse ]If the woman does not start menses after treatment cycle, pregnancy will be measured by serum hCG.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02572505
|United States, Missouri|
|Missouri Center for Reproductive Medicine & Fertility|
|Columbia, Missouri, United States|
|Principal Investigator:||Danny J Schust, M.D.||University of Missouri-Columbia|