Safety Study of UC-781 Vaginal Microbicide

NCT00446979 | Completed Phase 1

• 2 other identifiers: CDC-NCHHSTP-4744MOPH 109/2548
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

This study will help determine whether UC-781 gel is safe when applied to the vagina twice daily for 14 days, and will assess whether women and men find the gel acceptable to use.

Conditions

HIV Infections

Keywords

Microbicides; HIV seronegativity

Outcome Measures

Primary Outcomes (5)

• Genital tract inflammation or epithelial disruption as assessed by naked eye and colposcopic inspection according to established guidelines

  2 weeks

• Symptoms of irritation

  two weeks

• Changes in vaginal flora

  Two weeks

• Assessment of pro-inflammatory cytokines in the genital tract

  Two weeks

• Other product-related adverse events

  Two weeks

Secondary Outcomes (3)

• acceptability of UC-781 gel use

  Two weeks

• systemic absorption of UC-781

  Two weeks

• anti-HIV activity of genital secretions in the presence of UC-781 gel

  Two weeks

Study Arms (3)

1

EXPERIMENTAL

UC 781 0.1% carbomer gel

Drug: UC 781

2

EXPERIMENTAL

UC 781 0.25% carbomer gel

Drug: UC 781

3

PLACEBO COMPARATOR

Placebo vaginal gel

Drug: Placebo gel

Interventions

Placebo gel DRUG

HEC (hydroxyethyl cellulose) Control Gel applied vaginally twice daily for two weeks

3

UC 781 DRUG

UC 781 0.1% or UC 781 0.25%, applied vaginally twice daily for two intermenstrual weeks

1; 2

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-50 years old
• Regular menses
• HIV-1 seronegative at screening
• Normal Pap smear at screening or documented normal Pap smear within six months prior to screening
• No evidence of reproductive tract infection (RTI)
• Willing and able to comply with study procedures, including pelvic exams, colposcopy, maintaining a study coital and symptom log, and applying assigned study gel per protocol
• Agree to abstain from sexual intercourse for 24 hours prior to the enrollment visit
• Agree to abstain from the following activities from at least 48 hours prior to enrollment through the Day 14 visit:
• Insertion of fingers and other objects into the vagina
• Receiving oral sex
• Receiving anal sex
• Using a diaphragm, cervical cap, female condom, or vaginal contraceptive ring
• Using vaginal products other than the study gels, including douches, lubricants, or feminine hygiene products
• In a monogamous sexually active relationship with one male partner
• Report having vaginal intercourse only with that partner at least two times per week

You may not qualify if:

• Pregnancy or desire to become pregnant at time of study participation
• Currently breastfeeding
• Delivery or abortion within last eight weeks
• History of any male sexual partner other than current partner in past six months
• \- No abnormal (DAIDS grade 1 or higher) laboratory results at baseline, including hematology, liver and kidney function
• History of post-coital vaginal bleeding in the past three months
• History of surgery to remove uterus or cervix
• History of surgery on the external genitalia, vaginal, or cervix in the past month
• Clinically significant chronic medical condition that is considered progressive, including cardiopulmonary disease, renal disease, hepatic disease, diabetes mellitus.
• History of sensitivity/allergy to latex
• Existence of a clinically detectable genital abnormality at screening (e.g. ulcer, congenital abnormality, any lesion with mucosal disruption)
• Concurrent participation in another trial of a vaginal product
• Have any other condition that in the opinion of the investigator might interfere with the evaluation of the study objectives
• History of genital surgery in the past month
• Clinical or laboratory evidence of an STI.

Sponsors & Collaborators

• Centers for Disease Control and Prevention: lead
• Ministry of Health, Thailand: collaborator
• CONRAD: collaborator

Study Sites (1)

Chiang Rai Health Club

Chiang Rai, 57000, Thailand

Location

MeSH Terms

Conditions

HIV Infections

Interventions

UC-781

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Sara J Whitehead, MD, MPH

  Centers for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

• Chitlada Utaipiboon, MD

  Thailand MOPH - U.S. CDC Collaboration

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2007
• First Posted: March 13, 2007
• Study Start: June 1, 2007
• Study Completion: October 1, 2007
• Last Updated: April 19, 2013

Record last verified: 2013-04

Locations

TH (1)