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About
Study Objectives:
Study Summary:
MTN-011 will enroll heterosexual monogamous, sexually active couples, in which both partners are healthy and HIV-negative. The female participants must be between the ages of 21-46 (inclusive) and currently using effective non-barrier contraception. Male participants must be 21 years of age or older. This Phase 1 expanded safety study will assess tenofovir PK in the genital tract secretions (CVL), rectal (rectal sponge) and both intracellular and extracellular tissue compartments (vaginal biopsy) in the absence of, or following coitus. Pharmacodynamics (antiviral activity) will also be assessed in CVL. MTN-011 will study the timing in which coitus might have the greatest impact on these variables, which is when gel is applied shortly prior to coitus in the absence of a drug reservoir.
MTN-011 will examine PK/PD in response to a single dose of 1% tenofovir gel applied shortly before sex and compare to PK/PD assessments following a single gel application without sex. Additionally, data obtained from a visit in which participants do not dose with gel and do not have sex will serve as an additional control for the pharmacodynamic (PD) studies of the antiviral activity in CVL. If tenofovir retains its antiviral activity following sex, then the anti-HIV activity in CVL collected at the visit in which female participants dose with gel and have sex should be comparable to that of CVL collected at the visit in which females dose with gel and then do not engage in intercourse and significantly greater than the endogenous anti-HIV activity in CVL obtained at the visit in which participants do not dose with gel but do have sex and the visit in which no gel is administered and sex does occur. Data analysis performed after the completion of enrollment and follow-up procedures will demonstrate if there is an impact of coitus and semen on PK/PD when a single 1% tenofovir dose is applied shortly prior to sex.
Enrollment
Sex
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Volunteers
Inclusion criteria
Men and women must meet the following criteria to be eligible for inclusion in the study:
Able and willing to provide the following:
Per participant report, at low risk for HIV/STI. Low risk is defined as:
At Screening and Enrollment, both partners independently report not using barrier contraception and/or barrier protection as part of normal coital routine and report the intent to continue said sexual practice for the duration of study participation
HIV-uninfected based upon testing performed by study staff at Screening (per protocol algorithm)
Agrees not to participate in other research studies involving drugs, medical devices, or genital and rectal products, or large blood draw studies during study participation
Women must also meet the following criteria:
Note: Women with a documented normal result within the 12 months prior to screening need not have a Pap smear during the screening period. Women with abnormal Pap smears can be enrolled upon completion of the initial phase of evaluation if no current treatment is indicated (based on local standard of care for management of abnormal cervical cytology). Need for a repeat Pap within 6 months does not preclude enrollment prior to that result becoming available.
Note: This criterion is not applicable to participants using continuous combination oral contraceptive pills, as the absence of regular menstrual cycles is an expected, normal consequence in this context.
Men must also meet the following criteria:
Exclusion criteria
Men and women who meet any of the following criteria will be excluded from the study.
Participant report of any of the following:
At Screening or Enrollment, symptomatic urinary tract infection (UTI)
Note: Otherwise eligible participants diagnosed with UTI during screening are offered treatment and may be enrolled after completing treatment and all symptoms have resolved as long as treatment is completed and all symptoms have resolved within 30 days of obtaining informed consent for Screening/Enrollment.
At Screening, has a positive hepatitis B surface antigen (HBsAg) test result
At Screening or Enrollment, has an STI or reproductive tract infection (RTI) requiring treatment per current Centers for Disease Control (CDC) guidelines
Genital signs and/or symptoms of Grade 2 or higher
Note: For female participants, cervical bleeding associated with speculum insertion and/or specimen collection judged to be within the range of normal according to the clinical judgment of the IoR/designee is considered expected non-menstrual bleeding and is not exclusionary.
Note: Otherwise eligible participants with exclusionary genital findings may be enrolled after the findings have improved to a non-exclusionary severity grading or resolved as long as treatment is completed and all symptoms have resolved within 30 days of obtaining informed consent for Screening/Enrollment.
Has any other condition that, in the opinion of the Investigator of Record (IoR)/designee, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives
Women who meet any of the following criteria will be excluded from the study:
Participant report (or clinical finding) of the following:
Note: Self-reported pregnancy is adequate for exclusion from the study. A documented negative pregnancy test performed by study staff is required for inclusion.
Note: This does not include biopsy for the evaluation of an abnormal pap result or endometrial biopsy that occurred more than 7 days prior to Enrollment.
Any of the following laboratory abnormalities at Screening:
Note: Otherwise eligible participants with an exclusionary test may be re-tested during the screening process
Men who meet any of the following criteria will be excluded from the study:
Primary purpose
Allocation
Interventional model
Masking
31 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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