NCT00213018

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for phase_2 hiv-infections

Timeline
Completed

Started Oct 1999

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 1999

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2002

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
Last Updated

August 14, 2017

Status Verified

August 1, 2017

First QC Date

September 13, 2005

Last Update Submit

August 11, 2017

Conditions

HIV InfectionsChlamydia TrachomatisNeisseria GonorrhoeaeTrichomonas VaginitisSyphilis

Keywords

microbicidesHIV preventionsexually transmitted infectionsfemale-initiated protectioncarrageenanexpanded safety trialHIV SeronegativityHIV

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (1)

  • 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).

Interventions

Carraguard (PC-515)DRUG

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Cape Town, Department of Community Health

Cape Town, 7925, South Africa

Location

Medical University of Southern Africa

Soshanguve, 0204, South Africa

Location

MeSH Terms

Conditions

HIV InfectionsTrichomonas VaginitisSyphilisSexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesTrichomonas InfectionsProtozoan InfectionsParasitic DiseasesVaginitisVaginal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsTreponemal InfectionsSpirochaetales InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesSexually Transmitted Diseases, BacterialDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Charlotte E. Ellertson, MPA, Ph.D.

    Population Council

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

October 1, 1999

Study Completion

January 1, 2002

Last Updated

August 14, 2017

Record last verified: 2017-08

Locations

ZA(2)