Characterization and Modulation of Mucosal Immunity for HIV Prevention in Women

NCT02333045 | Terminated Results

• 1 other identifier: IRB00074767
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

HIV

Keywords

HIV-negative; Women; At-risk

Outcome Measures

Primary Outcomes (1)

• Count of Total Cells Obtained From Cervicovaginal Lavage Samples

  The count of CCR5+CD4+ T cells in the genital tract, before participants began study treatment, after 7 days of treatment, and during the post-treatment drug elimination period. The precise role of CCR5+CD4+ T cells in the female genital tract is unknown, however, higher cell counts may suggest the potential for more HIV target cells in the genital tract.

  Baseline, Day 7, Day 14, Day 21

Secondary Outcomes (2)

• Steady-state Area Under the Plasma Concentration-time Curve of Study Drug

  7 days

• Steady-state Area Under the Female Genital Tract Concentration-time Curve of Study Drug

  7 days

Study Arms (2)

Truvada qd

EXPERIMENTAL

Women will be assigned at random Truvada 1 tablet PO daily

Drug: Truvada qd

Maraviroc 300 qd

EXPERIMENTAL

Women will be assigned at random Maraviroc 300 mg PO daily

Drug: Maraviroc 300 qd

Interventions

Truvada qd DRUG

Truvada 1 tablet PO daily for 7 days

Also known as: Truvada

Truvada qd

Maraviroc 300 qd DRUG

Maraviroc 300 mg PO daily for 7 days

Also known as: Selzentry

Maraviroc 300 qd

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

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

Sponsors & Collaborators

• Emory University: lead

Study Sites (2)

Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

Location

Grady Infectious Diseases Clinic (Ponce Clinic)

Atlanta, Georgia, 30308, United States

Location

MeSH Terms

Interventions

Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Maraviroc

Intervention Hierarchy (Ancestors)

Tenofovir; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Emtricitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Drug Combinations; Pharmaceutical Preparations; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Triazoles; Azoles

Limitations and Caveats

In 2016, preliminary data analyses of a prior study and similar trials suggested minimal effects of a standard dose of maraviroc alone on cells of the female genital tract. Thus this intervention was discontinued early to minimize participant burden.

Results Point of Contact

• Title: Anandi Sheth, MD
• Organization: Emory University

ansheth@emory.edu

404-616-6240

Study Officials

• Anandi Sheth, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 5, 2015
• First Posted: January 7, 2015
• Study Start: January 1, 2015
• Primary Completion: October 28, 2016
• Study Completion: October 28, 2016
• Last Updated: January 19, 2018
• Results First Posted: December 13, 2017

Record last verified: 2017-12

Locations

US (2)