Safety and Acceptability of Carraguard™ Among HIV-negative Couples in Thailand

August 11, 2017 updated by: Population Council

A Randomized, Placebo-controlled, Double-blind Trial to Assess Expanded Safety and Acceptability of Carraguard™ (PC-515) Vaginal Gel Among Heterosexual Couples in Chiang Rai

The primary aims of the study were to assess the safety and acceptability of Carraguard applied vaginally prior to sexual intercourse for six months in both women and men; and to examine several dimensions of acceptability. Secondary aims were to gauge reactions to a non-contraceptive microbicide, to assess use dynamics among Thai couples and to observe preliminary indications of sexually transmitted infections and reproductive tract infections averted.

The hypothesis was that Carraguard would cause little or no significant irritation, including lesions; and that women and men would find Carraguard acceptable.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Carraguard™ (PC-515), the Population Council's lead candidate microbicide, was tested in a triple-masked, randomized, placebo-controlled trial fielded in one site in Chiang Rai, northern Thailand. The primary aims of the study were to assess Carraguard's safety (toxicity) in both men and women - including signs of local irritation, such as itching or burning; changes in vaginal flora (women); and incidence of abnormal external genital, vaginal (women), and cervical findings (women) - when applied vaginally prior to intercourse for 6 months; to evaluate acceptability; to gauge men's and women's reactions to a non-contraceptive microbicide; and to explore microbicide use dynamics in a Thai population.

Secondary aims were to investigate sexually transmitted infections averted - including HIV, C. trachomatis, N. gonorrhoeae, T. vaginalis, and T. pallidum (preliminary indications) in men and women; bacterial vaginosis and candidaisis in women; and balanitis in men; and effect on cervical cytology.

Study Type

Interventional

Enrollment

110

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

  • Thailand
      • Chiang Rai, Thailand, 57001
        • Chiang Rai Health Club

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • · In good health,

    • Aged 18 years or older,
    • Resident for at least 1 year; planning to stay for at least 12 months,
    • HIV-seronegative and free of all other STD at initial screening exam,
    • No reported sex partners other than current partner for prior year and and not planning on having any other sex partners for the duration of the study,
    • Not using condoms routinely (>25% of the time) in the prior year
    • Willing and able to comply with the study protocol (including being tested for HIV, learning the results, agreeing to partner notification if a curable STD is diagnosed, and undergoing clinical evaluations),
    • Able to achieve a score of 80% or better on true-false test of key study concepts, and
    • Able to give informed consent.
    • Planning to have vaginal sexual intercourse together on average at least once per week during the next six months.

Exclusion Criteria:

  • · Pregnant or desire to become pregnant at time of study participation,

    • Delivered or aborted a pregnancy within the six weeks prior to screening,
    • Male sex partner known at enrollment to be HIV positive,
    • History of surgery on external genitalia, vagina or cervix in the six weeks prior to screening,
    • Recent history of non-menstrual vaginal bleeding with intercourse,
    • Clinically detectable genital abnormality (including presence of warts, or a structural or congenital abnormality),
    • Genital epithelial disruption; men/women with healed lesions (intact epithelium) will be eligible,
    • Untreated symptomatic bacterial vaginosis or candidiasis. Women with asymptomatic BV or yeast may be enrolled. Women with treated symptomatic BV or candidaisis may be enrolled once no longer symptomatic. Women with signs or laboratory evidence of BV or candidaisis may be enrolled if they are asymptomatic. Women with symptoms of vaginal infection may be enrolled only if their enrollment visit stat laboratory evaluation is negative for BV, candidaisis or trichomoniasis,
    • Presence of balanitis. Men with resolved balanitis (e.g. through treatment) will be eligible,
    • Abnormal Pap smear (Class II or above),
    • History of sensitivity/allergy to latex,
    • Concurrent participation in another trial of a vaginal product,
    • Injection of recreational drugs.

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
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Safety (toxicity/local irritation): Genital exam and interview for signs and symptoms, 14-days after enrollment and monthly thereafter for 6 months; testing for bacterial vaginosis and candida (women) and balanitis (men) monthly.
Acceptability: Interview about gel use to assess compliance (monthly) and acceptability (quarterly).

Secondary Outcome Measures

Outcome Measure
Preliminary effectiveness: Swabs taken from women an urine specimens collected from men to test for sexually transmitted infections - gonorrhea, chlamydia, trichomoniasis (monthly) and for genital ulcer disease, if ulceration was detected; blood drawn

Collaborators and Investigators

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

Sponsor

Population Council

Collaborators

Bill and Melinda Gates Foundation
Centers for Disease Control and Prevention
Ministry of Health, Thailand
Chiang Rai Public Health Office
Chiang Rai District Health Office
Chiang Rai Municipal Health Office
Chiang Rai Hospital

Investigators

  • Principal Investigator: Kelly Blanchard, MSc, Population Council

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 Major Dates

Study Start (Actual)

June 1, 2001

Study Completion (Actual)

June 1, 2002

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 21, 2005

Study Record Updates

Last Update Posted (Actual)

August 14, 2017

Last Update Submitted That Met QC Criteria

August 11, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Population Council #270
  • CDC Protocol #2968

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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