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

NCT00213031 | Completed Phase 2

• 2 other identifiers: Population Council #271CDC & Prevention #2485
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections; Chlamydia Trachomatis; Neisseria Gonorrhoeae; Trichomonas Vaginitis; Syphilis; Herpes Simplex

Keywords

microbicides; HIV prevention; sexually transmitted infections; female-initiated protection; carrageenan; expanded safety trial; HIV Seronegativity; HIV

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• 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

Interventions

Carraguard (PC-515) DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Chiang Rai Health Club

Chiang Rai, 57001, Thailand

Location

MeSH Terms

Conditions

HIV Infections; Trichomonas Vaginitis; Syphilis; Herpes Simplex; Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Trichomonas Infections; Protozoan Infections; Parasitic Diseases; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Treponemal Infections; Spirochaetales Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Sexually Transmitted Diseases, Bacterial; Herpesviridae Infections; DNA Virus Infections; Skin Diseases, Viral; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Janneke HMM van de Wijgert, Ph.D.

  Population Council

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: February 1, 2000
• Study Completion: December 1, 2001
• Last Updated: August 14, 2017

Record last verified: 2017-08

Locations

TH (1)