Characterization and Modulation of Mucosal Immunity for HIV Prevention in Women

Stopped early · Not applicable

Conditions studied: HIV

In brief

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.

Key facts

Study ID

NCT02333045

Run by

Emory University

People needed

4

Starts

2015-01-01

Expected to finish

2016-10-28

Last updated by the study team

2018-01-19

Who can join

Age: 18 and older, up to 44. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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
• Injection drug use or use of crack, cocaine, heroin, or methamphetamine
• Diagnosed with a sexually transmitted infection
• Unprotected sex with 3 or more men
• Having sex for drugs, money, or shelter
• Sex with a known HIV-positive man
• 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:
• Absolute neutrophil count (ANC) ≥ 750/mm3
• Hemoglobin ≥ 10.0 g/dL
• Platelet count ≥ 100,000/mm3
• Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase ≤ 3 x Upper Limit Normal (ULN)
• Total bilirubin ≤ 2.5 x ULN
• 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

You may not qualify if…

• 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

Where it is running

• Grady Memorial Hospital — Atlanta, Georgia, United States
• Grady Infectious Diseases Clinic (Ponce Clinic) — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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