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

Primary Purpose

HIV Infections, Chlamydia Trachomatis, Neisseria Gonorrhoeae

Status
Completed
Phase
Phase 2
Locations
South Africa
Study Type
Interventional
Intervention
Carraguard (PC-515)
Sponsored by
Population Council
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring microbicides, HIV prevention, sexually transmitted infections, female-initiated protection, carrageenan, expanded safety trial, HIV Seronegativity, HIV

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of Cape Town, Department of Community Health
  • Medical University of Southern Africa

Outcomes

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).

Full Information

First Posted
September 13, 2005
Last Updated
August 11, 2017
Sponsor
Population Council
Collaborators
Bill and Melinda Gates Foundation, FHI 360, National Institute of Allergy and Infectious Diseases (NIAID), Medical Research Council, South Africa, University of Cape Town, University of Limpopo, United States Agency for International Development (USAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00213018
Brief Title
Safety, Acceptability and Preliminary Effectiveness of Carraguard™ (PC-515) in Preventing HIV/STI Transmission
Official Title
A Trial to Assess Expanded Safety, Acceptability and Preliminary Effectiveness of Carraguard™ (PC-515) in Preventing STI/HIV Transmission
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
October 1999 (Actual)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2002 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Population Council
Collaborators
Bill and Melinda Gates Foundation, FHI 360, National Institute of Allergy and Infectious Diseases (NIAID), Medical Research Council, South Africa, University of Cape Town, University of Limpopo, United States Agency for International Development (USAID)

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Chlamydia Trachomatis, Neisseria Gonorrhoeae, Trichomonas Vaginitis, Syphilis
Keywords
microbicides, HIV prevention, sexually transmitted infections, female-initiated protection, carrageenan, expanded safety trial, HIV Seronegativity, HIV

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
400 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Carraguard (PC-515)
Primary Outcome Measure Information:
Title
Safety (toxicity): Symptoms 14 days after enrollment and monthly thereafter (6-12 months); tests (monthly) to detect change in vaginal flora;
Title
Compliance: collection of applicators and interview(monthly)
Title
Acceptability: interview (quarterly)
Secondary Outcome Measure Information:
Title
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).

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charlotte E. Ellertson, MPA, Ph.D.
Organizational Affiliation
Population Council
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Cape Town, Department of Community Health
City
Cape Town
ZIP/Postal Code
7925
Country
South Africa
Facility Name
Medical University of Southern Africa
City
Soshanguve
ZIP/Postal Code
0204
Country
South Africa

12. IPD Sharing Statement

Learn more about this trial

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

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