NCT00006207

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for phase_1 hiv-infections

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 11, 2000

Completed
12 months until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

July 30, 2008

Status Verified

June 1, 2003

First QC Date

September 11, 2000

Last Update Submit

July 29, 2008

Conditions

HIV Infections

Keywords

HIV SeropositivityDose-Response Relationship, DrugHIV SeronegativityMucous MembraneUlcerVaginaAnti-HIV AgentsSexual AbstinenceIrritantsPRO 2000

Interventions

PRO 2000DRUG

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.
  • +5 more criteria

You may not qualify if:

  • 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.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Julia Welch

Research Triangle Park, North Carolina, 27709, United States

Location

Related Publications (1)

  • Mayer KH, Karim SA, Kelly C, Maslankowski L, Rees H, Profy AT, Day J, Welch J, Rosenberg Z; HIV Prevention Trials Network (HPTN) 020 Protocol Team. Safety and tolerability of vaginal PRO 2000 gel in sexually active HIV-uninfected and abstinent HIV-infected women. AIDS. 2003 Feb 14;17(3):321-9. doi: 10.1097/00002030-200302140-00005.

    PMID: 12556685BACKGROUND

MeSH Terms

Conditions

HIV InfectionsHIV SeropositivityUlcerSexual Abstinence

Interventions

PRO 2000

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsSexual BehaviorBehavior

Study Officials

  • Ken Mayer

    STUDY CHAIR

  • Salim Abdool Karim

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
PREVENTION
Sponsor Type
NIH

Study Record Dates

First Submitted

September 11, 2000

First Posted

August 31, 2001

Last Updated

July 30, 2008

Record last verified: 2003-06

Locations

US(1)