Safety and Tolerability of the Vaginal Gel PRO 2000/5

July 29, 2008 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

A Phase I Multicenter Dose Escalation Safety and Acceptability Study of the Investigational Vaginal Microbicide Agent PRO 2000/5 Gel (P)

The purpose of this study is to determine whether the vaginal gel PRO 2000/5 causes irritation when used daily.

Studies have shown PRO 2000/5 is safe and well tolerated as a vaginal gel in healthy women who are not sexually active. However, it was not determined what side effects to skin in the vaginal area there might be in sexually active women.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Vaginal microbicides are designed to inhibit the sexual transmission of HIV-1 and other disease pathogens. Two Phase I clinical trials were conducted to evaluate the safety and tolerance of the gel, PRO 2000/5, in sexually abstinent volunteers. Both demonstrated that multiple application of the gel was safe and well tolerated in healthy, sexually abstinent women but no clear association between the use of the gel and epithelial disruption was indicated. Because genital ulceration and inflammation may increase the risk of HIV infection, additional clinical evaluation of PRO 2000/5 gel is warranted, especially for study participants with active sexual behavior.

Participants apply PRO 2000/5 gel intravaginally either once or twice daily for 14 days. HIV-negative participants in sexually active cohorts (Cohorts A1-A4) are instructed to engage in vaginal intercourse at least twice a week. Participants in the HIV-positive cohort (Cohort B1) abstain from sexual intercourse for the dosing period. Researchers conduct physical exams to see if the gel is having any harmful effects on the woman's vulva, vagina, or cervix. Women and their male partners are questioned about gel usage.

Study Type

Interventional

Enrollment

60

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Research Triangle Park, North Carolina, United States, 27709
        • Julia Welch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria

Volunteers may be eligible for this study if they:

  • Are female and 18-45 years of age.
  • Are willing and able to complete daily study records.
  • Are willing to undergo clinical exams and testing.
  • Either have regular menstrual periods or do not menstruate due to use of hormones.
  • Agree to stop using female barrier methods of birth control during the study.
  • Additionally, volunteers may be eligible for HIV-negative groups in this study if they:
  • Have not changed their use of hormonal birth control over the last 3 months.
  • Are HIV-negative.
  • Have a single male partner at low-risk for HIV infection and agree that he can be asked for his consent.
  • Agree to the following: To have vaginal intercourse 2 or more times a week; to use condoms provided by the study for each act of intercourse; to use the gel as directed; not to be in similar studies; not to receive oral sex; not to use IV drugs, except for medical treatment; not to use any other vaginal products; not to douche; and not to use vaginal drying agents.
  • Additionally, volunteers may be eligible for the HIV-positive group in this study if they:
  • Are HIV-positive.
  • Have a CD4 count greater than 200 cells/mm3.
  • Have a normal Pap smear at screening.
  • Are on stable anti-HIV drug therapy.
  • Agree to have no sexual intercourse during the study.
  • Have HIV care by qualified medical caregivers.
  • Agree to allow study staff access to their HIV medical care information.
  • Agree to the following: To use the gel as directed; not to use IV drugs other than for medical treatment; not to use any other vaginal products; not to participate in similar studies; not to receive oral sex; not to douche; and not to use any vaginal drying agents.

Exclusion Criteria

Volunteers will not be eligible for this study if they:

  • Are menopausal.
  • Have certain liver, kidney, or blood problems.
  • Have genital problems such as sores.
  • Are allergic to anything used in the study, including latex.
  • Have used spermicides or condoms treated with spermicides within the week before enrollment.
  • Have been in another drug study within the past 30 days.
  • Have participated in this trial before and study gel has been permanently discontinued.
  • Have had an IUD or begun using hormonal birth control, or had an abnormal Pap smear, a pregnancy, an abortion, gynecologic surgery, breakthrough menstrual bleeding, or vaginal bleeding during or following sexual intercourse, in the last 3 months.
  • Have had or received treatment for sexually transmitted diseases in the past 3 months.
  • Show signs, on a pelvic exam, indicating a sexually transmitted disease or other genital tract problems.
  • Used IV drugs, except for medical reasons, within the past year.
  • Received antibiotics in the last 14 days.
  • Have had a reaction to an anticoagulant (such as warfarin or heparin).
  • Are pregnant or breast-feeding.
  • Have a positive urine culture.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators

Procept

Investigators

  • Study Chair: Ken Mayer
  • Study Chair: Salim Abdool Karim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

September 11, 2000

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

July 30, 2008

Last Update Submitted That Met QC Criteria

July 29, 2008

Last Verified

June 1, 2003

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HIVNET 020

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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