Interventional Study of Mucosal and Antimicrobial Responses to Repeated Vaginal Applications of Tenofovir Gel in HIV Uninfected Women

NCT00594373 | Completed Phase 1 DMC

• 3 other identifiers: TFV 01010443U01AI069551
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Topical microbicides, substances that kill microbes, are being studied to prevent sexual transmission of HIV and other disease-causing agents. In the future, topical microbicides may be applied vaginally to prevent both acquisition and transmission of HIV and other sexually transmitted infections (STIs). The purpose of this study is to assess whether there is a measurable response to daily applications of a topical microbicide, 1% tenofovir gel, in women at low risk for HIV infection.

Conditions

HIV Infections

Keywords

Microbicide; HIV Seronegativity

Outcome Measures

Primary Outcomes (1)

• Changes in cytokines, chemokines, and other mediators of innate immunity through examination of cervicovaginal secretions

  At Days 3, 7, 14, and 21

Secondary Outcomes (1)

• Changes in antimicrobial activity of cervicovaginal secretions

  At Day 14

Study Arms (2)

1

EXPERIMENTAL

Application of 1% tenofovir gel for 14 consecutive days between menses

Drug: Tenofovir gel

2

PLACEBO COMPARATOR

Application of 1% tenofovir placebo gel for 14 consecutive days between menses

Drug: Tenofovir gel placebo

Interventions

Tenofovir gel DRUG

1 gm/100 ml of 1% tenofovir gel vaginally daily

Also known as: TFV, 9-(2-[Phosphonomethoxy]propyl)adenine

1

Tenofovir gel placebo DRUG

1 gm/100 ml of placebo gel vaginally daily

2

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Normal menstrual history with regular cycles and with a minimum of 21 days between menses
• Sexually abstinent or in a stable, mutually monogamous relationship with a partner who is HIV uninfected
• Agree to abstain from sexual intercourse and to not use vaginal products within 48 hours of study entry and for the duration of the study

You may not qualify if:

• HIV infected
• Sexually transmitted infection within 6 months of study entry
• Use of nontherapeutic intravenous drugs within 12 months of study entry
• Menopausal
• Currently using hormonal contraception or have used hormonal contraception within 2 months of study entry
• Menstruating at screening or enrollment visits
• Positive urine culture
• Positive chlamydia, gonorrhea, or trichomonas result at screening
• Abnormal Pap smear
• Clinically detectable genital abnormality. More information on this criterion can be found in the protocol.
• History of toxic shock syndrome or a history of symptoms suggesting toxic shock syndrome
• History of intermenstrual bleeding within 3 months of study entry
• Previous gynecologic surgery or have received treatment for syphilis, genital herpes, chlamydia, gonorrhea, trichomonas, or genital warts within 6 months of study entry
• Received treatment for Candida, bacterial vaginosis, or urinary tract infection within 1 month of study entry
• Have douched or used vaginal products, including lubricants, feminine hygiene products, vaginal drying agents, and sex toys within 48 hours of study entry

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

Albert Einstein College of Medicine - East Campus GCRC (Herold) Non-Network CRS

The Bronx, New York, 10461, United States

Location

Related Publications (3)

• Bateman C. Tenofovir gel--the new HIV prevention 'banker'? S Afr Med J. 2007 Jul;97(7):496, 498. No abstract available.

  PMID: 17805450 BACKGROUND

• Mayer KH, Maslankowski LA, Gai F, El-Sadr WM, Justman J, Kwiecien A, Masse B, Eshleman SH, Hendrix C, Morrow K, Rooney JF, Soto-Torres L; HPTN 050 Protocol Team. Safety and tolerability of tenofovir vaginal gel in abstinent and sexually active HIV-infected and uninfected women. AIDS. 2006 Feb 28;20(4):543-51. doi: 10.1097/01.aids.0000210608.70762.c3.

  PMID: 16470118 BACKGROUND

• Keller MJ, Madan RP, Torres NM, Fazzari MJ, Cho S, Kalyoussef S, Shust G, Mesquita PM, Louissaint N, Chen J, Cohen HW, Diament EC, Lee AC, Soto-Torres L, Hendrix CW, Herold BC. A randomized trial to assess anti-HIV activity in female genital tract secretions and soluble mucosal immunity following application of 1% tenofovir gel. PLoS One. 2011 Jan 25;6(1):e16475. doi: 10.1371/journal.pone.0016475.

  PMID: 21283552 DERIVED

MeSH Terms

Conditions

HIV Infections

Interventions

hexadecyloxypropyl 9-(2-(phosphonomethoxy)propyl)adenine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Marla Keller, MD

  Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

• Betsy Herold, MD

  Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2008
• First Posted: January 15, 2008
• Primary Completion: November 1, 2009
• Study Completion: April 1, 2010
• Last Updated: November 1, 2021

Record last verified: 2021-10

Locations

US (1)