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

This study has been completed.
Sponsor:
Collaborators:
Ministry of Health, Thailand
Chiang Rai Public Health Office
Chiang Rai District Health Office
Chiang Rai Municipal Health Office
Chiang Rai Hospital
Bill and Melinda Gates Foundation
Information provided by:
Population Council
ClinicalTrials.gov Identifier:
NCT00213057
First received: September 13, 2005
Last updated: December 21, 2005
Last verified: September 2002
  Purpose

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.


Condition Intervention Phase
HIV Infections
Chlamydia Trachomatis
Nesseria Gonorrhea
Trichomonas Vaginitis
Syphilis
Drug: Carraguard (PC-515)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Population Council:

Primary Outcome Measures:
  • 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:
  • 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

Estimated Enrollment: 110
Study Start Date: June 2001
Estimated Study Completion Date: June 2002
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  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: NCT00213057

Locations
Thailand
Chiang Rai Health Club
Chiang Rai, Thailand, 57001
Sponsors and Collaborators
Population Council
Ministry of Health, Thailand
Chiang Rai Public Health Office
Chiang Rai District Health Office
Chiang Rai Municipal Health Office
Chiang Rai Hospital
Bill and Melinda Gates Foundation
Investigators
Principal Investigator: Kelly Blanchard, MSc Population Council
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00213057     History of Changes
Other Study ID Numbers: Population Council #270, CDC Protocol #2968
Study First Received: September 13, 2005
Last Updated: December 21, 2005
Health Authority: United States: Food and Drug Administration
Thailand: Food and Drug Administration

Keywords provided by Population Council:
Microbicides
HIV prevention
sexually transmitted infections
carrageenan
sero-concordant couples
HIV Seronegativity
HIV

Additional relevant MeSH terms:
Trichomonas Vaginitis
Vaginitis
Infection
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
Trichomonas Infections
Protozoan Infections
Parasitic Diseases
Vaginal Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on September 30, 2014