Safety, Acceptability and Preliminary Effectiveness of PC-515 for Vaginal Use as a Possible Microbicide

This study has been completed.
Sponsor:
Collaborators:
Bill and Melinda Gates Foundation
Nat'l Cntr. for HIV, STD, & TB Prevention Atlanta: Division of STD Prevention,Div. of HIV/AIDS Prevention—Surveillance & Epidemiology
National Center for Infectious Diseases
Ministry of Health, Thailand
Collaboration (TUC)
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:
NCT00213031
First received: September 13, 2005
Last updated: May 10, 2006
Last verified: September 2002
  Purpose

The primary aims of the study were to assess the safety and acceptability of PC-515 when applied vaginally at least three times weekly for 12 months. Secondary aims were to gather preliminary data on Carraguard’s effectiveness in preventing male-to-female transmission of HIV, and other STIs.

The hypothesis was that Carraguard would cause little or no significant irritation, including lesions; and that women would find Carraguard acceptable. The study was not powered to determine effectiveness, but based on safety, acceptability and feasibility parameters, the outcome of the Phase 2 trial would enable a decision whether or not to proceed to a Phase 3 trial.


Condition Intervention Phase
HIV Infections
Chlamydia Trachomatis
Neisseria Gonorrhoeae
Trichomonas Vaginitis
Syphilis
Herpes Simplex
Drug: Carraguard (PC-515)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Educational/Counseling/Training
Official Title: A Randomized, Placebo-Controlled, Double-Blind Trial to Assess Expanded Safety, Acceptability and Preliminary Effectiveness of PC-515 (Lambda Carrageenan) for Vaginal Use as a Possible Microbicide

Resource links provided by NLM:


Further study details as provided by Population Council:

Primary Outcome Measures:
  • Safety: Genital exam & interview for symptoms after 14 days & monthly thereafter; colposcopy done throughout trial at clinicians' discretion; monthly testing to detect changes in vagina flora.
  • Compliance: collection of applicators and interview(monthly)
  • Acceptability: interview (quarterly)

Secondary Outcome Measures:
  • Preliminary effectiveness: Swabs taken to test for sexually transmitted infections – gonorrhea, chlamydia, trichomoniasis and for genital ulcer disease, if ulceration was detected; blood drawn for syphilis and HIV testing and for HSV-2 Pap smear to det

Estimated Enrollment: 165
Study Start Date: February 2000
Estimated Study Completion Date: December 2001
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) – including signs of local irritation, such as itching or burning; changes in vaginal flora; and incidence of abnormal external genital, vaginal, and cervical findings – when applied vaginally for 12 months; to evaluate acceptability; to assess feasibility of conducting a large scale microbicide trial in a non-sex worker population; to gauge women’s reactions to a non-contraceptive microbicide; and to explore microbicide use dynamics in a Thai population.

Secondary aims were to investigate HIV infections averted (preliminary indications); other sexually transmitted infections averted – including C. trachomatis, N. gonorrhoeae, T. vaginalis, and T. pallidum (preliminary indications); and effect on cervical cytology.

  Eligibility

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

Inclusion Criteria:

  • In good health as determined by medical history, physical examination and results of laboratory screening tests
  • Aged 18 years or older
  • Resident in the area for at least one year and planning to stay for at least 12 months
  • HIV-seronegative at baseline
  • Willing and able to comply with the study protocol (including being tested for HIV, learning the results, and undergoing clinical evaluations)
  • Able to achieve a score of 80% or better on true-false test of key study concepts
  • Able to give informed consent

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)
  • Clinical suspicion of a reproductive tract infection (RTI), defined as the presence of a genital ulcer visible to the naked eye, an abnormal vaginal discharge or purulent cervicitis, or untreated positive STD result (Women could be enrolled after treatment of identified RTI. Women with persistent genital epithelial disruption, i.e., ulcer, abrasion or fissure, were not eligible.
  • Women with other persistent abnormal signs, such as vaginal or cervical discharge, despite treatment of identified RTI, were 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: NCT00213031

Locations
Thailand
Chiang Rai Health Club
Chiang Rai, Thailand, 57001
Sponsors and Collaborators
Population Council
Bill and Melinda Gates Foundation
Nat'l Cntr. for HIV, STD, & TB Prevention Atlanta: Division of STD Prevention,Div. of HIV/AIDS Prevention—Surveillance & Epidemiology
National Center for Infectious Diseases
Ministry of Health, Thailand
Collaboration (TUC)
Chiang Rai Public Health Office
Chiang Rai District Health Office
Chiang Rai Municipal Health Office
Chiang Rai Hospital
Investigators
Principal Investigator: Janneke HMM van de Wijgert, Ph.D. Population Council
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00213031     History of Changes
Other Study ID Numbers: Population Council #271, CDC & Prevention #2485
Study First Received: September 13, 2005
Last Updated: May 10, 2006
Health Authority: United States: Food and Drug Administration
Thailand: Food and Drug Administration

Keywords provided by Population Council:
microbicides
HIV prevention
sexually transmitted infections
female-initiated protection
carrageenan
expanded safety trial
HIV Seronegativity
HIV

Additional relevant MeSH terms:
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immune System Diseases
Slow Virus Diseases
Sexually Transmitted Diseases, Bacterial
Genital Diseases, Male
Genital Diseases, Female
Skin Diseases, Viral
Skin Diseases, Infectious
Skin Diseases
Parasitic Diseases
Vaginal Diseases
HIV Infections
Acquired Immunodeficiency Syndrome
Chlamydia Infections
Gonorrhea
Herpes Simplex
Syphilis
Trichomonas Infections
Trichomonas Vaginitis
Vaginitis
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Immunologic Deficiency Syndromes
Chlamydiaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Infection

ClinicalTrials.gov processed this record on August 20, 2014