Characterization and Modulation of Mucosal Immunity for HIV Prevention in Women (MIP)

Emory University

Status

Terminated

Conditions

HIV

Treatments

Drug: Truvada qd

Drug: Maraviroc 300 qd

Study type

Interventional

Funder types

Other

Identifiers

NCT02333045

IRB00074767

Details and patient eligibility

About

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.

Full description

In this study, the investigator seeks to understand the immune cells in the cervical fluid 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. Maraviroc works by preventing HIV from entering human immune cells by blocking a protein on the outside of these cells called the C-C chemokine receptor type 5 (CCR5) receptor. When maraviroc is bound to this protein, the virus cannot enter the cell. The investigator thinks that CCR5 antagonists could be particularly good drugs for HIV pre-exposure prophylaxis (PrEP) and could potentially be dosed in ways that are easier to take than the current drugs used for PrEP.

In order to further evaluate this PrEP strategy, the investigator will first study the immune cells in the blood and genital tract of HIV-negative healthy female volunteers over the course of 3 months to see how these cells change over time and are affected by factors such as age, menstrual cycle, and genital infections.

The amount of maraviroc compared with the drugs in the current drugs used for PrEP (tenofovir/ emtricitabine) in the blood and genital tract of HIV-negative healthy female volunteers before, during, and after they are given maraviroc versus tenofovir/ emtricitabine for 7 days will be measured. We will also study immune cells from the blood and genital tract from these women to see if maraviroc, tenofovir, or emtricitabine have an effect on these cells that would prevent them from becoming infected with HIV.

Enrollment

4 patients

Sex

Female

Ages

18 to 44 years old

Volunteers

Accepts Healthy Volunteers

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