Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2025-12-25 @ 3:44 AM
NCT ID:
NCT03701802
Eligibility Criteria:
Inclusion criteria:
HIV-1 Uninfected Participants;
* Age ≥18 and ≤65 and able to provide independent informed consent for research per local regulations and guidelines
* Able and willing to provide written informed consent to be screened for and to take part in the study
* Part of a heterosexual couple in which either one or both partners meet the study eligibility criteria for partner (HIV-1 uninfected) participants. Couples are defined by the following criteria:
* Partners are sexually active (defined as having had vaginal intercourse with the enrolled partner at least 6 times in the last three months)
* Partners plan to remain in the relationship for the duration of the study period.
* HIV-1 uninfected status is based on parallel negative HIV-1 rapid tests, both at study screening and at the enrollment visit
* Able and willing to provide adequate locator information for study retention purposes, as defined by local standard operating procedures
HIV-1 Infected Participants;
* Of legal age to provide independent informed consent for research per local regulations and guidelines.
* Able and willing to provide written informed consent to be screened for and to take part in the study.
* Part of a heterosexual couple in which one partner meets the study eligibility criteria for index (HIV-1 infected) participants and the other partner meets the study eligibility criteria for partner (HIV-1 uninfected) participants
* Current or previous use of antiretroviral therapy with unsuppressed HIV-1 viral load
* HIV-1 infected based on positive EIA and, when available, detectable viral load.
* No history of any clinical AIDS-defining diagnoses.
* Able and willing to provide adequate locator information for study retention purposes, as defined by local standard operating procedures.
Exclusion criteria:
HIV-1 Uninfected Participants;
* Abnormal serum creatinine (based on sub-Saharan African normal values)
* Active and serious infections, including active tuberculosis infection or osteomyelitis and all infections requiring parenteral antibiotic therapy; active clinically significant medical problems including cardiac disease, pulmonary disease, diabetes requiring hypoglycemic medication; and previously diagnosed malignancy expected to require further treatment.
* Receiving ongoing therapy with any of the following at the time of enrollment: antiretroviral therapy (ART), including nucleoside analogs, nonnucleoside reverse transcriptase inhibitors, protease inhibitors or investigational antiretroviral agents, interferon (alpha, beta, or gamma) or interleukin (e.g., IL-2) therapy, metformin, aminoglycoside antibiotics, amphotericin B, cidofovir, systemic chemotherapeutic agents, other agents with significant nephrotoxic potential, other agents that may inhibit or compete for elimination via active renal tubular secretion (e.g., probenecid), and/or other investigational agent
* At enrollment, has any other condition that, based on the opinion of the investigator or designee, would preclude provision of informed consent; make participation in the study unsafe; complicate interpretation of study outcome data)
* Pregnant at the time of screening
HIV-1 Infected Participants;
* Current or previous use of antiretroviral therapy with suppressed HIV-1 viral load
* Currently enrolled in another HIV-1 treatment trial
* At enrollment, has any other condition that, based on the opinion of the investigator or designee, would preclude provision of informed consent; make participation in the study unsafe; complicate interpretation of study outcome data; or otherwise interfere with achieving the study objectives.
* Pregnant at the time of screening
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03701802
Study Brief:
Protocol Section:
NCT03701802