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

Sponsor

Population Council (Other)

Overall Status

Completed

CT.gov ID

NCT00213031

Collaborator

Bill and Melinda Gates Foundation (Other), Centers for Disease Control and Prevention (U.S. Fed), Nat'l Cntr. for HIV, STD, & TB Prevention Atlanta: Division of STD Prevention,Div. of HIV/AIDS Prevention-Surveillance & Epidemiology (Other), National Center for Infectious Diseases (Other), Ministry of Health, Thailand (Other), Collaboration (TUC) (Other), Chiang Rai Public Health Office (Other), Chiang Rai District Health Office (Other), Chiang Rai Municipal Health Office (Other), Chiang Rai Hospital (Other)

165

Enrollment

Location

Actual Duration (Months)

7.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

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.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Other

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

Actual Study Start Date :

Feb 1, 2000

Actual Study Completion Date :

Dec 1, 2001

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Chiang Rai Health Club	Chiang Rai		Thailand	57001

Sponsors and Collaborators

Population Council
Bill and Melinda Gates Foundation
Centers for Disease Control and Prevention
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