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 @ 2:08 AM
Ignite Modification Date:
2025-12-25 @ 2:08 AM
NCT ID:
NCT01283360
Eligibility Criteria:
Inclusion Criteria for Participants in Stage 1A (non sex-workers):
1. Willing and able to provide written informed consent to take part in the study
2. Willing and able to communicate in English or Spanish
3. Must agree not to participate in other drug trials
4. Biologically male and identifies as male
5. Age 18-30 years at screening
6. HIV-1 status antibody negative or unknown per patient report
7. Understands and agrees to local STI reporting requirements
8. Able and willing to provide adequate information for locator purposes
9. Availability to return for all study visits, barring unforeseen circumstances
10. A history of consensual RAI at least once in past month
11. Reporting at least one occasion of unprotected RAI in the prior year\* In order to identify participants at increased risk for acquiring HIV
Inclusion Criteria for Participants in Stage 1A (sex-workers):
1. Willing and able to provide written informed consent to take part in the study
2. Willing and able to communicate in English or Spanish
3. Must agree not to participate in other drug trials
4. Biologically male, including male-to-female transgender women
5. Age 18-30 years at screening
6. HIV-1 status antibody negative or unknown per patient report
7. Understands and agrees to local STI reporting requirements
8. Able and willing to provide adequate information for locator purposes
9. Availability to return for all study visits, barring unforeseen circumstances
10. A history of consensual RAI at least once in past month
11. Reporting at least one occasion of unprotected RAI in the prior year\*
12. Reporting at least two occasions of RAI as part of transactional sex (i.e., having received money or other goods/services in exchange for sex) in the prior 2 months\*
* In order to identify participants at increased risk for acquiring HIV
Inclusion Criteria for Participants in Stage 1B (both sex workers and non sex-workers):
1. Completed Stage 1A
2. HIV-1 uninfected at screening based on HIV rapid test results
3. Reports unprotected RAI in the prior three months on at least one occasion\* In order to obtain acceptability data from individuals most likely to benefit from microbicide availability
4. Availability to return for all Stage 1B visits, barring unforeseen circumstances
Inclusion Criteria for Participants in Stage 2:
1. Completed study stage 1AB
2. HIV-1 uninfected at screening based on HIV rapid test results
3. Availability to return for all Stage 2 visits, barring unforeseen circumstances
Exclusion Criteria for Participants in Stage 1A (both sex workers and non sex-workers):
1\. Any condition or prior therapy that, in the opinion of the investigator, would make study participation unsafe, make the individual unsuitable for the study or unable to comply with the study requirements. Such conditions may include, but are not limited to, current or recent history of severe, progressive, or uncontrolled substance abuse, or renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, or cerebral disease
Exclusion Criteria for Participants in Stage 1B (both sex workers and non sex-workers):
1. Clinical or laboratory diagnosis of active rectal infection requiring treatment per current CDC guidelines. Infections requiring treatment include Chlamydia (CT), gonorrhea (GC), syphilis, active HSV lesions, chancroid, genital sores or ulcers, and if clinically indicated, genital warts. Note that an HSV-2 seropositive diagnosis with no active lesions is allowed, since treatment is not required
2. Positive Hepatitis B surface antigen test indicating hepatitis B infection
3. Allergy to methylparaben, propylparaben, or latex
4. History of significant drug allergy or recurrent urticaria
5. History of inflammatory bowel disease
6. Currently engage or plan to engage in unprotected RAI with HIV-infected partners
7. By participant report planning to receive another investigational drug while participating in this study
8. Any other condition or prior therapy that, in the opinion of the investigator, would make study participation unsafe, make the individual unsuitable for the study or unable to comply with the study requirements. Such conditions may include, but are not limited to, current or recent history of severe, progressive, or uncontrolled substance abuse, or renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, or cerebral disease
Exclusion Criteria for Participants in Stage 2:
1. Meet any of the exclusion criteria for Stage 1B
2. Reporting a history of transactional sex (i.e., having received money or other goods/services in exchange for sex) in the prior 6 months
3. Undergoing or completed gender reassignment
4. Grade 2 or higher liver function, creatinine, coagulation, electrolyte, or hematology abnormality in accordance with DAIDS toxicity table values (normal values based on site specific laboratory criteria) at screening (or Visit 2 PT/INR for coagulation), and confirmed by retest/and or redraw
5. History of significant gastrointestinal bleeding
6. History of inflammatory bowel disease
7. Abnormalities of the rectal mucosa, or significant rectal symptom(s), which in the opinion of the clinician represents a contraindication to biopsy (including but not limited to presence of any unresolved injury, infectious or inflammatory condition of the local mucosa, and presence of symptomatic external hemorrhoids
8. Per participant report, anticipated use and/or unwillingness to abstain from the following medications during the period of Stage 2 study participation:
1. Heparin, including Lovenox®
2. Warfarin
3. Plavix® (clopidogrel bisulfate)
4. Aspirin \>81 mg per day
5. Non-steroidal anti-inflammatory drugs (NSAIDS)
6. Any other drugs that are associated with increased likelihood of bleeding following rectal biopsy
9. By participant report, use of systemic immunomodulatory medications within the 4 weeks prior to the Stage 2 Enrollment Visit and throughout study participation
10. By participant report, use of rectally administered medications, rectally administered products (including condoms) containing N-9, or any investigational products within the 2 weeks or 10 half-lives of the drug, whichever is longer, prior to the Stage 2 Enrollment Visit, or is planning to receive another investigational drug while participating in this study
11. Any other condition or prior therapy that, in the opinion of the investigator, would make study participation unsafe, make the individual unsuitable for the study or unable to comply with the study requirements. Such conditions may include, but are not limited to, current or recent history of severe, progressive, or uncontrolled substance abuse, or renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, or cerebral disease -
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
30 Years
Study:
NCT01283360
Study Brief:
Protocol Section:
NCT01283360