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

This study has been completed.
Sponsor:
Collaborators:
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
Information provided by:
Population Council
ClinicalTrials.gov Identifier:
NCT00213044
First received: September 13, 2005
Last updated: October 21, 2005
Last verified: October 2004
  Purpose

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 Intervention Phase
HIV Infections
Drug: Carraguard (PC-515)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Population Council:

Primary Outcome Measures:
  • 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).
  • Genital tract HIV: measured using samples collected by CVL (Day 7, 14) and vaginal swab (Day 7, 14).
  • Acceptability: interview-administered questionnaire (Day 7).

Estimated Enrollment: 60
Study Start Date: March 2003
Estimated Study Completion Date: June 2004
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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00213044

Locations
Thailand
Chiang Rai Health Club
Chiang Rai, Thailand, 57001
Sponsors and Collaborators
Population Council
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
Investigators
Principal Investigator: Janneke van de Wijgert, PhD Population Council
Principal Investigator: Catherine McClean Centers for Disease Control and Prevention
  More Information

No publications provided by Population Council

Additional 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
Study First Received: September 13, 2005
Last Updated: October 21, 2005
Health Authority: United States: Food and Drug Administration
Thailand: Food and Drug Administration

Keywords provided by Population Council:
Microbicides
HIV prevention
HIV-positive women
safety
carrageenan
HIV

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

ClinicalTrials.gov processed this record on August 19, 2014