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A Randomized, Controlled, Cross-Over Trial of Safety of Vaginal Use of Carraguard by HIV-Infected Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00213044
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : August 15, 2017
Information provided by:

Study Description
Brief Summary:
Randomized, controlled, double-blinded, cross-over trial of 60 HIV-infected women recruited from general medical clinics, family planning clinics, groups/organizations working with persons living with AIDS to assess product safety, effect on genital tract HIV shedding, and product acceptability with vaginal use of Carraguard gel among HIV-infected women. Women had to be abstinent or in a seroconcordant relationship with only one partner for the study period.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Carraguard (PC-515) Phase 1

Detailed Description:

Carraguard™ (PC-515), the Population Council's lead candidate microbicide, was tested in a randomized, controlled trial in Chiang Rai, northern Thailand. Safety of daily product use determined by symptoms of irritation, effect on vaginal flora, vaginal epithelial disruption as determined by naked eye inspection (Day 7 and Day 14 of each arm) and colposcopic inspection on (Day 7), and other adverse effects, which may include UTI or other unforeseen problems (Day 7 and Day 14).

Genital tract HIV will be measured using samples collected by CVL (Day 7 and Day 14 of each arm) and vaginal swab (Day 7 and Day 14).

Product acceptability will be assessed through an interview-administered questionnaire once each study arm at the first follow-up visit (Day 7 of each arm), after using the product daily for 7 days.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: A Randomized, Controlled, Double-Blind, Cross-Over Trial of Safety, Effect on Genital Tract HIV Shedding, and Acceptability of Vaginal Use of Carraguard by HIV-Infected Women
Actual Study Start Date : March 2003
Study Completion Date : June 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. Safety: irritation, effect on vaginal flora, vaginal epithelial disruption determined by visual inspection (Day 7, 14) and colposcopic inspection(Day 7); other adverse effects, which may include UTI or other unforeseen problems (Day 7, 14).
  2. Genital tract HIV: measured using samples collected by CVL (Day 7, 14) and vaginal swab (Day 7, 14).
  3. Acceptability: interview-administered questionnaire (Day 7).

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age 18-50 years
  • Plan to stay in the Chiang Rai area for at least four months
  • HIV-infected, confirmed by Elisa and Western Blot tests
  • Either has 1) no current sex partner and is planning to be abstinent for the study duration, or 2) has only one, HIV-infected sexual partner1 who is 18 years or older and is willing to give informed consent for confirmatory HIV testing and for the participant=s enrollment in the study. Women who have a steady partner/husband who she will not see during the study period or with whom she is not sexually active will not be required to bring their partner to the clinic for HIV testing and informed consent.
  • Willing and able to give informed consent
  • Willing and able to comply with the study protocol, including being tested for HIV and undergoing repeated pelvic and colposcopic examinations
  • Willing to have male partner asked for informed consent because he will be exposed to study product
  • Regular menstrual cycles (defined as occurring every 3-5 weeks, lasting 3-5 days) for the prior 3 months; if have amenorrhea or if using depo-provera, participant must have no reported history of vaginal bleeding for the previous 3 months
  • CD4 count < 5002
  • Not currently taking antiretroviral medications3
  • Documented Class I or Class II ("atypical cells seen, usually caused by inflammation") pap smear at screening for study participation
  • In good health as determined by medical history, physical examination and results of any laboratory screening test, and the discretion of the clinical staff
  • Able to achieve a score of 80% or better on true-false test of key study concepts. If women score less than 80% the first time they take the test, they may repeat the test at least one day later

Exclusion Criteria:

  • CD4 count <50
  • Pregnancy or desire to become pregnant in the next 3-4 months
  • Delivery, miscarriage, or abortion within six weeks prior to study enrollment
  • History of surgery on external genitalia, vagina or cervix in the month prior to study enrollment
  • Existence of a clinically detectable genital abnormality, specifically warts or a congenital abnormality
  • History of nonmenstrual vaginal bleeding with intercourse in past one month
  • Current use of tampons, diaphragms, sponges, douching, or other intravaginal products. Women who are willing to abstain from using these products during the study will be included in the study.
  • Concurrent participation in another trial of a vaginal product
  • History of sensitivity or allergy to latex products (including gloves)
  • Presence of epithelial disruption of the labia or genital mucosa visible to the naked eye at enrollment1
  • Positive test for gonorrhea, chlamydial infection, trichomoniasis, or evidence of untreated syphilis (see section 5.19). Participants with positive tests must be treated and have a negative test of cure to be eligible for enrollment.1
  • Positive tests for candidiasis or bacterial vaginosis (BV) and symptoms of vaginitis. Women may be enrolled after treatment if they are asymptomatic or have negative tests. Asymptomatic participants with positive tests for candidiasis or BV may be enrolled.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00213044

Chiang Rai Health Club
Chiang Rai, Thailand, 57001
Sponsors and Collaborators
Population Council
Centers for Disease Control and Prevention
National Center for HIV STD and TB Prevention
National Center for Infectious Diseases
Ministry of Health, Thailand
Chiang Rai Public Health Office
Chiang Rai District Health Office
Chiang Rai Municipal Health Office
Chiang Rai Hospital
Principal Investigator: Janneke van de Wijgert, PhD Population Council
Principal Investigator: Catherine McClean Centers for Disease Control and Prevention
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00213044     History of Changes
Other Study ID Numbers: Population Council #316
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: August 15, 2017
Last Verified: August 2017

Keywords provided by Population Council:
HIV prevention
HIV-positive women

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases