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:
2025-12-24 @ 2:03 PM
Ignite Modification Date:
2025-12-24 @ 2:03 PM
NCT ID:
NCT01632995
Eligibility Criteria:
Inclusion Criteria:
* Must be either a man who has sex with men or a transgender female
* Male sex (at birth)
* Willing and able to provide written informed consent
* HIV-1 uninfected, defined as having a negative rapid HIV antibody test at both screening visit and enrollment and a negative 4th generation antibody/antigen test at screening
* No laboratory evidence of a detectable HIV viral load (San Francisco site only)
* Evidence of risk of acquiring HIV-1 infection including any one of the following:
(1) Condomless anal sex with two or more male or transgender female sex partners during the last 12 months; or (2) two or more episodes of anal sex with at least one HIV-positive partner during the last 12 months; or (3) sex with a male or transgender female partner and any of the following STDs diagnosed during the last 12 months or at screening: syphilis, rectal gonorrhea, or rectal chlamydia.
* Able to provide a street address of residence or phone number for themselves or two personal contacts who would know their whereabouts during the period of the demonstration project
* Adequate renal function: creatinine clearance of 60 ml/min or greater as estimated by the Cockcroft-Gault equation within 45 days of enrollment
* A urine dipstick with a negative or trace result for protein within 45 days of enrollment
* Fluent in English or in Spanish
Exclusion Criteria:
* Signs or symptoms of acute HIV infection
* Previously diagnosed active and serious infections including active tuberculosis infection or osteomyelitis and all infections requiring parenteral antibiotic therapy (other than STDs requiring intramuscular injections of antibiotics); active clinically significant medical problems including poorly controlled cardiac disease (e.g., symptoms of ischemia or congestive heart failure) or previously diagnosed malignancy expected to require further treatment
* Hepatitis B surface antigen (HBsAg) positive
* History of pathological bone fractures not related to trauma
* Receiving ongoing therapy with any of the following: investigational antiretroviral agents (PEP is allowed as described in the protocol), interferon (alpha, beta, or gamma) or interleukin (e.g., IL-2) therapy, 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 agents
* Concomitant participation in a clinical trial using investigational agents, including placebo-controlled clinical trials using such agents
* 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 project unsafe; complicate interpretation of outcome data; or otherwise interfere with achieving the project objectives
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT01632995
Study Brief:
Protocol Section:
NCT01632995