Pre-Exposure Prophylaxis and Timed Intercourse for HIV-Discordant Couples
Status:
Withdrawn
Trial end date:
2017-09-20
Target enrollment:
Participant gender:
Summary
Human immunodeficiency virus (HIV) infection has now become a treatable disease and many
infected individuals are interested in having a family. Couples in which the man is infected
but the woman is HIV-negative (hereafter referred to as HIV-discordant) require medical
intervention during procreation to prevent HIV transmission to the female and her child. The
current view is that reducing the number of infections involving unprotected intercourse in
HIV-discordant couples is a public health issue in the U.S. The safest methods for
HIV-discordant couples are insemination using a sperm donor, adoption and remaining
childless. However, some couples strongly desire a biologically related child. Fertility
clinics in the United States have been resistant to treating HIV-discordant couples, offering
only expensive, invasive techniques. This reduces access to care, leading to couples choosing
unprotected intercourse to conceive a child. Pre-exposure prophylaxis (PrEP) is a treatment
taken by the woman before having unprotected intercourse with an infected man. Truvada has
been approved by the Food and Drug Administration (FDA) to reduce the risk of HIV-discordant
couples and the Centers for Disease Control and prevention (CDC) has recommended that
serodiscordant patients who wish to have a child be counseled on the availability of PrEP.
When risks of transmission are minimized, including undetectable HIV in blood and use of
PrEP, unprotected intercourse during the fertile period is likely to be a safe option for
conceiving a child. 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.
Phase:
N/A
Details
Lead Sponsor:
University of Missouri-Columbia
Treatments:
Emtricitabine Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination Tenofovir