Pre-Exposure Prophylaxis and Timed Intercourse for HIV-Discordant Couples

• Status: Withdrawn
• Trial end date: 2017-09-20
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Missouri-Columbia
• Treatments: Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Tenofovir

Criteria

Inclusion Criteria:

Woman:

• 18-40 years of age

• not pregnant

• BMI 18.5-30

• nonsmoker

• no use of IV drugs

• seronegative for HIV

• negative tests for hepatitis C and hepatitis B, human T-lymphotropic virus (HTLV I&II), syphilis, Chlamydia trachomatis and Neisseria gonorrhea

• normal fertility examination

• normal PAP smear and HPV screen

Man:

• 18-50 years of age

• nonsmoker

• no use of IV drugs

• HIV-seropositive

• under the care of an infectious disease specialist

• without evidence of acquired immunodeficiency syndrome (AIDS)

• HIV viral load <50,000 copies/mL and CD4 count > 250 cells/mL for the preceding 6 month period

• taking anti-retroviral medication

• must be circumcised

• have 2 normal semen analyses

Couple:

• must be informed of safer choices (donor insemination, adoption, remaining childless)

• must attest to safe sexual practices.

Exclusion Criteria:

• either man or woman is incarcerated

• either man or woman is unable to provide informed consent

• woman is unable to take Truvada (tenofovir/emtricitabine) medication due to contraindications or adverse reaction