Safety, Acceptability and Preliminary Effectiveness of Carraguard™ (PC-515) in Preventing HIV/STI Transmission

This study has been completed.
Sponsor:
Collaborators:
Bill and Melinda Gates Foundation
FHI 360
Medical Research Council, South Africa
University of Cape Town
University of Limpopo
United States Agency for International Development (USAID)
Information provided by:
Population Council
ClinicalTrials.gov Identifier:
NCT00213018
First received: September 13, 2005
Last updated: October 21, 2005
Last verified: September 2004
  Purpose

The primary aims of the study were to assess the safety and acceptability of Carraguard ™ (PC-515) when applied vaginally at least three times weekly for 6-12 months. Secondary aims were to gather preliminary data on Carraguard’s effectiveness in preventing male-to-female transmission of HIV.

The hypothesis was that Carraguard would cause little or no significant irritation, including lesions; 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 efficacy trial.


Condition Intervention Phase
HIV Infections
Chlamydia Trachomatis
Neisseria Gonorrhoeae
Trichomonas Vaginitis
Syphilis
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: Prevention
Official Title: A Trial to Assess Expanded Safety, Acceptability and Preliminary Effectiveness of Carraguard™ (PC-515) in Preventing STI/HIV Transmission

Resource links provided by NLM:


Further study details as provided by Population Council:

Primary Outcome Measures:
  • Safety (toxicity): Symptoms 14 days after enrollment and monthly thereafter (6-12 months); tests (monthly) to detect change in vaginal 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 (monthly) and blood drawn for syphilis and HIV testing (Month 1 and quarterly thereafter).

Estimated Enrollment: 400
Study Start Date: October 1999
Estimated Study Completion Date: January 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 two sites in South Africa. The primary aims of the study were to assess Carraguard’s safety (toxicity) – including signs of irritation, such as itching or burning; changes in vaginal flora; and incidence of abnormal external genital, vaginal, and cervical findings – when applied vaginally for durations of 6-12 months, and to evaluate several dimensions of the acceptability of Carraguard and placebo products. Secondary aims were to investigate whether study participants using Carraguard had lower rates of HIV seroconversion or other sexually transmitted infections (including C. trachomatis, N. gonorrhoeae, T. vaginalis, and T. pallidum) than the placebo (methyl cellulose gel). In addition, when it began, this trial was the first to explore the feasibility of large-scale microbicides testing in a non-sex worker population. Last, the trial gauged women’s reactions to using a non-contraceptive product (in vitro testing had shown that Carraguard has no contraceptive effect), as well as potential use-dynamics in communities where drying agents and other traditional vaginal products are used with high frequency.

  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 for RTIs
  • 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 screening
  • Willing and able to comply with the study protocol (including being tested for HIV, learning the results, and undergoing clinical evaluations), and,
  • Able to give informed consent

Exclusion Criteria:

  • Pregnant or desire to become pregnant during the trial
  • Delivered or aborted a pregnancy within the six weeks prior to screening
  • 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 RTI (defined as the presence of a genital ulcer visible to the naked eye, an abnormal vaginal discharge or purulent cervicitis, or untreated positive STI test result)
  • Abnormal Pap smear
  • History of sensitivity/allergy to latex
  • Participating in another trial of a vaginal product
  • Reported 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: NCT00213018

Locations
South Africa
University of Cape Town, Department of Community Health
Cape Town, South Africa, 7925
Medical University of Southern Africa
Soshanguve, South Africa, 0204
Sponsors and Collaborators
Population Council
Bill and Melinda Gates Foundation
FHI 360
Medical Research Council, South Africa
University of Cape Town
University of Limpopo
United States Agency for International Development (USAID)
Investigators
Principal Investigator: Charlotte E. Ellertson, MPA, Ph.D. Population Council
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00213018     History of Changes
Other Study ID Numbers: Population Council #210, RO1-AI45468-02
Study First Received: September 13, 2005
Last Updated: October 21, 2005
Health Authority: United States: Food and Drug Administration
South Africa: Medicines Control Council

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:
Acquired Immunodeficiency Syndrome
HIV Infections
Infection
Trichomonas Vaginitis
Genital Diseases, Female
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Parasitic Diseases
Protozoan Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Trichomonas Infections
Vaginal Diseases
Vaginitis
Virus Diseases

ClinicalTrials.gov processed this record on October 29, 2014