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Pre-Exposure Prophylaxis and Timed Intercourse for HIV-Discordant Couples (PrEP-HIVD)

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ClinicalTrials.gov Identifier: NCT02572505
Recruitment Status : Withdrawn
First Posted : October 9, 2015
Last Update Posted : October 6, 2017
Sponsor:
Information provided by (Responsible Party):
Erma Drobnis, University of Missouri-Columbia

Brief 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.

Condition or disease Intervention/treatment Phase
HIV Infertility Drug: Truvada Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Truvada

Arm Intervention/treatment
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.
Drug: Truvada
Female patient will take Truvada and use condoms for each act of intercourse except once at the optimal time for fertility.
Other Names:
  • HIV-D
  • PrEP
  • Gilead Sciences
  • emtricitabine
  • tenofovir disoproxil fumarate




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02572505


Locations
United States, Missouri
Missouri Center for Reproductive Medicine & Fertility
Columbia, Missouri, United States
Sponsors and Collaborators
University of Missouri-Columbia
Investigators
Principal Investigator: Danny J Schust, M.D. University of Missouri-Columbia

Additional Information:
Publications:

Responsible Party: Erma Drobnis, Assistant Professional Practice Professor, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT02572505     History of Changes
Other Study ID Numbers: IRB #2002937
First Posted: October 9, 2015    Key Record Dates
Last Update Posted: October 6, 2017
Last Verified: October 2017

Keywords provided by Erma Drobnis, University of Missouri-Columbia:
HIV-Discordant
Preexposure Prophylaxis

Additional relevant MeSH terms:
Genital Diseases, Female
Anti-HIV Agents
Infertility
Genital Diseases, Male
Emtricitabine
Tenofovir
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents