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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

165 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-02-29

Study Completion Date

2001-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT00213018

HIV Infections Chlamydia Trachomatis Neisseria Gonorrhoeae +2 more

COMPLETED PHASE2

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

NCT00213057

HIV Infections Chlamydia Trachomatis Nesseria Gonorrhea +2 more

COMPLETED PHASE1

Efficacy Study of the Vaginal Gel Carraguard to Prevent HIV Transmission

NCT00213083

HIV Infections AIDS Sexually Transmitted Diseases +1 more

COMPLETED PHASE3

Lubricant Investigation in Men to Inhibit Transmission of HPV Infection

NCT02354144

Human Papillomavirus Infection

TERMINATED PHASE2/PHASE3

Study of UC-781 Vaginal Microbicide

NCT00132444

HIV Infections

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HIV Infections Chlamydia Trachomatis Neisseria Gonorrhoeae Trichomonas Vaginitis Syphilis Herpes Simplex

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Carraguard (PC-515)

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes