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

NCT00213057 | Completed Phase 1

• 2 other identifiers: Population Council #270CDC Protocol #2968
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aims of the study were to assess the safety and acceptability of Carraguard applied vaginally prior to sexual intercourse for six months in both women and men; and to examine several dimensions of acceptability. Secondary aims were to gauge reactions to a non-contraceptive microbicide, to assess use dynamics among Thai couples and to observe preliminary indications of sexually transmitted infections and reproductive tract infections averted. The hypothesis was that Carraguard would cause little or no significant irritation, including lesions; and that women and men would find Carraguard acceptable.

Conditions

HIV Infections; Chlamydia Trachomatis; Nesseria Gonorrhea; Trichomonas Vaginitis; Syphilis

Keywords

Microbicides; HIV prevention; sexually transmitted infections; carrageenan; sero-concordant couples; HIV Seronegativity; HIV

Outcome Measures

Primary Outcomes (2)

• Safety (toxicity/local irritation): Genital exam and interview for signs and symptoms, 14-days after enrollment and monthly thereafter for 6 months; testing for bacterial vaginosis and candida (women) and balanitis (men) monthly.

• Acceptability: Interview about gel use to assess compliance (monthly) and acceptability (quarterly).

Secondary Outcomes (1)

• Preliminary effectiveness: Swabs taken from women an urine specimens collected from men to test for sexually transmitted infections - gonorrhea, chlamydia, trichomoniasis (monthly) and for genital ulcer disease, if ulceration was detected; blood drawn

Interventions

Carraguard (PC-515) DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• · In good health,
• Aged 18 years or older,
• Resident for at least 1 year; planning to stay for at least 12 months,
• HIV-seronegative and free of all other STD at initial screening exam,
• No reported sex partners other than current partner for prior year and and not planning on having any other sex partners for the duration of the study,
• Not using condoms routinely (\>25% of the time) in the prior year
• Willing and able to comply with the study protocol (including being tested for HIV, learning the results, agreeing to partner notification if a curable STD is diagnosed, and undergoing clinical evaluations),
• Able to achieve a score of 80% or better on true-false test of key study concepts, and
• Able to give informed consent.
• Planning to have vaginal sexual intercourse together on average at least once per week during the next six months.

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),
• Genital epithelial disruption; men/women with healed lesions (intact epithelium) will be eligible,
• Untreated symptomatic bacterial vaginosis or candidiasis. Women with asymptomatic BV or yeast may be enrolled. Women with treated symptomatic BV or candidaisis may be enrolled once no longer symptomatic. Women with signs or laboratory evidence of BV or candidaisis may be enrolled if they are asymptomatic. Women with symptoms of vaginal infection may be enrolled only if their enrollment visit stat laboratory evaluation is negative for BV, candidaisis or trichomoniasis,
• Presence of balanitis. Men with resolved balanitis (e.g. through treatment) will be 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
• Centers for Disease Control and Prevention: collaborator
• Ministry of Health, Thailand: collaborator
• Chiang Rai Public Health Office: collaborator
• Chiang Rai District Health Office: collaborator
• Chiang Rai Municipal Health Office: collaborator
• Chiang Rai Hospital: collaborator
• Bill and Melinda Gates Foundation: collaborator

Study Sites (1)

Chiang Rai Health Club

Chiang Rai, 57001, Thailand

Location

MeSH Terms

Conditions

HIV Infections; Trichomonas Vaginitis; Syphilis; 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; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kelly Blanchard, MSc

  Population Council

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• 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: June 1, 2001
• Study Completion: June 1, 2002
• Last Updated: August 14, 2017

Record last verified: 2017-08

Locations

TH (1)