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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02572505 |
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Date of registration:
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06/10/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Pre-Exposure Prophylaxis and Timed Intercourse for HIV-Discordant Couples
PrEP-HIVD |
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Scientific title:
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Pre-Exposure Prophylaxis and Timed Intercourse for HIV-Discordant Couples |
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Date of first enrolment:
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November 2015 |
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Target sample size:
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0 |
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Recruitment status: |
Withdrawn |
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URL:
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https://clinicaltrials.gov/show/NCT02572505 |
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Study type:
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Interventional |
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Study design:
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Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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United States
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Contacts
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Name:
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Danny J Schust, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Missouri-Columbia |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
40 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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HIV
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Infertility
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Intervention(s)
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Drug: Truvada
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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Proportion of couples achieving pregnancy after each treatment menstrual cycle.
[Time Frame: Approximately one month after unprotected intercourse]
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Secondary ID(s)
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IRB #2002937
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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