Characterization and Modulation of Mucosal Immunity for HIV Prevention in Women

• Status: Terminated
• Trial end date: 2016-10-28
• Target enrollment: 0
• Participant gender: Female

Summary

This study seeks to understand the immune cells in the cervical fluid of in the blood and genital tract of HIV-negative healthy female volunteers and to see if these cells can be modified using a combined anti-viral and antiinflammatory drug called maraviroc, a medicine used in the treatment of HIV infection.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Emory University
• Treatments: Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Maraviroc

Criteria

Inclusion Criteria:

• Age 18-44 years

• Must be biologically female (defined as sex at birth)

• HIV negative women with at least one of the following risk factors in the past 5 years

1. Injection drug use or use of crack, cocaine, heroin, or methamphetamine

2. Diagnosed with a sexually transmitted infection

3. Unprotected sex with 3 or more men

4. Having sex for drugs, money, or shelter

5. Sex with a known HIV-positive man

6. Having a partner meeting any of the preceding criteria

• Normal menses (within 22-35 day intervals) for at least 3 cycles

• No history of alcohol abuse, heart disease, or liver disease, or any other medical condition that would interfere with the conduct of the study, in the opinion of the study investigator

• No history of loop electrosurgical excision procedure (LEEP), conization, or cryosurgery

• Normal chemistry, liver function, and complete blood count panels at screening, including:

1. Absolute neutrophil count (ANC) ≥ 750/mm3

2. Hemoglobin ≥ 10.0 g/dL

3. Platelet count ≥ 100,000/mm3

4. Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase ≤ 3 x Upper Limit Normal (ULN)

5. Total bilirubin ≤ 2.5 x ULN

6. Creatinine Clearance (CrCl) ≥ 60 mL/min as estimated by the Cockcroft-Gault equation

• Negative hepatitis B surface antigen (HBsAg)

• No signs or symptoms of orthostasis

• No signs or symptoms of vaginal infection or genital ulcer disease at screening or untreated vaginal infection in the last 30 days

• Not receiving concurrent medications that interact with maraviroc (MVC) or any antiretrovirals (such as tenofovir/ emtricitabine [Truvada®]) for the purpose of HIV prevention

• Willing to use condoms for the duration of the study and abstain from sexual intercourse for 48 hours before each genital tract sampling

Exclusion Criteria:

• Male sex (defined as sex at birth)

• Pregnant or breastfeeding

• Current use of systemic hormonal contraception

• Symptomatic vaginal infection or genital ulcer disease at screening or treatment for vaginal infection in the last two weeks

• Active malignancy for which the participant is undergoing evaluation and/or treatment

• Immunosuppressive medications (i.e, systemic steroids)

• Any surgery in the preceding 2 months