Safety and Acceptability of the Anti-Microbe Vaginal Gel, PMPA Gel

NCT00028132 | Completed Phase 1

• 2 other identifiers: HPTN 05010696
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 5

Brief Summary

The purpose of this study is to evaluate the PMPA gel, which kills microbes, in HIV-infected and HIV-uninfected women. The majority of new HIV infections occur through heterosexual contact. A product that stops or slows the replication of HIV during sexual contact is needed. At present, there are no products that are completely effective. PMPA gel, also known as tenofovir, is an anti-microbe agent that may fight against sexual transmission of HIV and other sexually transmitted diseases (STDs). It is applied to the vagina and gives women the ability to control their disease-prevention activity.

Conditions

HIV Infections

Keywords

Risk Factors; Mucous Membrane; Anti-Infective Agents; Cervix Uteri; Vagina; Anti-HIV Agents; Pharmacokinetics; Vulva; 9-(2-phosphonylmethoxypropyl)adenine; HIV Seronegativity

Interventions

Tenofovir DRUG

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• All female participants may be eligible for this study if they:
• Are between 18 and 45 years of age.
• Have a menstrual cycle with at least 21 days between periods or have not menstruated for at least 6 months.
• Agree from the time of Screening Visit until the Day 14 Follow-up Visit to: a) not use IV drugs (except for therapeutic use) and b) not participate in other microbicide or contraceptive studies.
• Agree not to take part in the following activities for at least 48 hours before the study enrollment visit (Day 0) until the Day 14 Follow-up Visit: anal intercourse; douching; oral contact with the vagina; penetration of the vagina by fingers, sex toys, or any other objects; use of any vaginal product, including lubricants, drying agents, feminine hygiene products, diaphragms, and cervical caps.
• Agree to insert the PMPA gel in the exact way it is specified.
• Abstinent Women (Groups A1-A4, C, and V) may be eligible for this study if they:
• Agree to abstain from vaginal intercourse from 48 hours before study until Day 14.
• HIV-infected abstinent women (C) must be HIV infected; have a CD4 count of at least 200/mm3 at time of screening and within 6 months prior to screening, and a viral load of 10,000 copies/ml or less if on anti-HIV therapy or have a viral load of less than 55,000 if not on anti-HIV therapy; provide study staff access to HIV medical records and be under medical care for HIV management; and be on stable anti-HIV therapy (if any) for 1 month before screening and expect to stay on that therapy throughout the study.
• Sexually Active Women (Groups B and D) may be eligible for this study if they:
• Agree to abstain from vaginal intercourse for 48 hours before study start.
• Agree to tell their mutually monogamous male sexual partner about their participation in the trial and of requirements from Day 0 until Day 14 to have vaginal intercourse at least twice weekly and to use a study-provided male latex condom for every sexual episode.
• HIV-uninfected sexually active women (B) must currently have a single male HIV-uninfected sexual partner who is at low risk for HIV infection and who can be included in the study.
• HIV-infected sexually active women (D) must have a CD4 count of at least 200/mm3 at time of screening and within 6 months prior to screening, and a viral load of 10,000 copies/ml or less if on anti-HIV therapy or have a viral load of less than 55,000 if not on anti-HIV therapy; provide study staff access to HIV medical records and be under medical care for HIV management; be on stable anti-HIV therapy (if any) for 1 month before screening and expect to stay on that therapy throughout the study; and currently have a single male HIV-infected sexual partner who can be included in the study.
• Male sexual partners of sexually active participants (Groups B and D) must be:

You may not qualify if:

• Female participants may not be eligible for this study if they:
• Have gone through menopause.
• Have had a hysterectomy.
• Are breast-feeding.
• Are using or have used within the past year IV drugs (except for therapeutic use).
• Are pregnant.
• Have serious liver, kidney, or blood problems.
• Have had antibiotic therapy in the 14 days before study start.
• Have taken part in other microbicide or contraceptive studies within 1 month of study start.
• Have been previously enrolled in this study.
• Have any genital abnormalities.
• Are sensitive or allergic to any substances used in the study.
• Are unwilling to use 1 of the following methods of contraception during the study unless surgically sterilized: non N-9 condoms, hormonal contraceptives, abstinence.
• Have used any spermicide or condoms that have spermicide on them within 1 week before study start.
• Have used a hormonal contraceptive method for less than 3 months before study start.

Sponsors & Collaborators

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

Study Sites (5)

Harlem Prevention Ctr. CRS (El-Sadr CTU)

New York, New York, 10037, United States

Location

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

The Bronx, New York, 10457, United States

Location

3535 Market Street CRS

Philadelphia, Pennsylvania, 19104, United States

Location

The Miriam Hosp., Div. of Infectious Disease

Providence, Rhode Island, 02906, United States

Location

Women & Infants' Hosp.

Providence, Rhode Island, 02906, United States

Location

Related Publications (2)

• 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 RESULT

• Carballo-Dieguez A, Balan IC, Morrow K, Rosen R, Mantell JE, Gai F, Hoffman S, Maslankowski L, El-Sadr W, Mayer K. Acceptability of tenofovir gel as a vaginal microbicide by US male participants in a Phase I clinical trial (HPTN 050). AIDS Care. 2007 Sep;19(8):1026-31. doi: 10.1080/09540120701294237.

  PMID: 17852000 RESULT

MeSH Terms

Conditions

HIV Infections

Interventions

Tenofovir

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

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Lisa Maslankowski

  STUDY CHAIR

• Kenneth Mayer

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2001
• First Posted: December 14, 2001
• Study Completion: December 1, 2005
• Last Updated: November 1, 2021

Record last verified: 2021-10

Locations

US (5)