Safety and Acceptability of a Vaginal Microbicide

NCT00111943 | Completed Phase 2

• 2 other identifiers: HPTN 05910145
• Study Type: interventional
• Target: 200
• Locations: 2 countries
• Sites: 3

Brief Summary

The purpose of this study is to determine the safety and acceptability of a vaginal microbicide in HIV uninfected sexually active women. Study hypothesis: The vaginal microbicide 1% tenofovir will be safe and well tolerated in HIV uninfected women who are in good general health.

Conditions

HIV Infections; Hepatitis B, Chronic

Keywords

Anti-Infective Agents, Local; HIV Seronegativity; Tenofovir; Vaginal gel; Microbicide; Vaginal Microbicide; PMPA

Outcome Measures

Primary Outcomes (1)

• Macroscopic evidence of damage to the cervical, vulvar, or vaginal epithelium, including ulceration and other lesions, severe erythema, or severe edema, related or not related to the study gel or applicator

Secondary Outcomes (2)

• Adherence to the study gel regimen

• acceptability of the study gel

Interventions

1% tenofovir gel DRUG

Eligibility Criteria

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

You may qualify if:

• HIV uninfected
• Good general health
• Sexually active
• Willing to use acceptable methods of contraception, including male latex condoms for all acts of intercourse
• Willing to undergo all study-related assessments and adhere to the requirements of the study

You may not qualify if:

• Menopausal or postmenopausal
• Hysterectomy
• Abnormal screening results for several gynecologic exams
• Taking or planning to take tenofovir, adefovir, or any other medication for chronic HBV infection
• History of latex allergy
• History of adverse reaction to tenofovir or adefovir
• Use of a diaphragm or spermicide for contraception
• Prior participation in the study
• Prior participation in any vaginal microbicide, spermicide, or other drug study within 30 days of study entry
• Gynecologic surgical procedure within 90 days of study entry
• Illicit injection drug use within 12 months of study entry
• History of vaginal intercourse more than an average of two times per day in the two weeks prior to study screening
• Any other criteria that, in the investigator's opinion, may interfere with the study
• Current pregnancy or previous pregnancy within 90 days of study entry
• Breastfeeding

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• National Institute on Drug Abuse (NIDA): collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (3)

Alabama Microbicide CRS

Birmingham, Alabama, 35294-0022, United States

Location

Bronx- Lebanon Hospital Center Clinical Research Site (BLHC CRS)

The Bronx, New York, United States

Location

NARI Arogya Aadhar Clinic CRS

Pune, Maharashtra, 411002, India

Location

Related Publications (5)

• Bentley ME, Fullem AM, Tolley EE, Kelly CW, Jogelkar N, Srirak N, Mwafulirwa L, Khumalo-Sakutukwa G, Celentano DD. Acceptability of a microbicide among women and their partners in a 4-country phase I trial. Am J Public Health. 2004 Jul;94(7):1159-64. doi: 10.2105/ajph.94.7.1159.

  PMID: 15226137 BACKGROUND

• D'Cruz OJ, Uckun FM. Clinical development of microbicides for the prevention of HIV infection. Curr Pharm Des. 2004;10(3):315-36. doi: 10.2174/1381612043386374.

  PMID: 14754390 BACKGROUND

• Mantell JE, Myer L, Carballo-Dieguez A, Stein Z, Ramjee G, Morar NS, Harrison PF. Microbicide acceptability research: current approaches and future directions. Soc Sci Med. 2005 Jan;60(2):319-30. doi: 10.1016/j.socscimed.2004.05.011.

  PMID: 15522488 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

• Van Damme L. Clinical microbicide research: an overview. Trop Med Int Health. 2004 Dec;9(12):1290-6. doi: 10.1111/j.1365-3156.2004.01338.x.

  PMID: 15598260 BACKGROUND

Related Links

• Click here for the Alliance for Microbicide Development Web site

MeSH Terms

Conditions

HIV Infections; Hepatitis B, Chronic

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; Hepatitis B; Hepadnaviridae Infections; DNA Virus Infections; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sharon Hillier, PhD

  Department of Obstetrics and Gynecology and Reproductive Sciences, Magee-Women's Hospital

  STUDY CHAIR

• Jessica Justman, MD

  Bronx-Lebanon Hospital Center

  STUDY CHAIR

• Smita N. Joshi, MBBS

  National AIDS Research Institute (NARI)

  STUDY CHAIR

• Craig Hoesley, MD

  University of Alabama at Birmingham

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2005
• First Posted: May 27, 2005
• Study Completion: October 1, 2007
• Last Updated: November 1, 2021

Record last verified: 2021-10

Locations

US (2); IN (1)