Study of UC-781 Vaginal Microbicide

NCT00132444 | Completed Phase 1

• 1 other identifier: CDC-NCHSTP-4413
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

This study will help determine whether the agent UC-781, formulated as a gel, is safe when applied to the vagina twice daily for 14 days. It will also assess whether women find the gel acceptable to use.

Conditions

HIV Infections

Keywords

HIV; topical microbicides

Outcome Measures

Primary Outcomes (3)

• Macroscopic and/or microscopic evidence of cervical, vulvar and/or vaginal epithelial damage, including ulceration, abrasion, severe erythema, and or severe edema.

  with two weeks of administration

• Symptoms of genital irritation, including burning, itching or soreness

  With 2 weeks of administration

• Laboratory evidence of grade 3 or higher toxicity for hematology, liver or renal function which cannot be attributed to another cause

  with 2 weeks of administration

Secondary Outcomes (1)

• Acceptability of 0.1% and 0.25% UC-781 gel use by HIV-uninfected and HIV-infected women

  queried after 2 weeks of administation

Study Arms (3)

1

ACTIVE COMPARATOR

0.25% gel

Drug: topical vaginal application of UC-781 gel

2

ACTIVE COMPARATOR

0.1% gel

Drug: topical vaginal application of UC-781 gel

3

PLACEBO COMPARATOR

Drug: topical vaginal application of UC-781 gel

Interventions

topical vaginal application of UC-781 gel DRUG

UC-781 gel (arms 1 and 2) or placebo (arm 3) applied vaginally twice daily for 14 days

1; 2; 3

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• For All Females:
• Ages 18-45 years of age
• Able to provide written informed consent
• Normal Pap smear at screening or documentation of such within six months prior
• Regular monthly menses or amenorrhea due to hormonal contraceptive use
• Agree to pelvic exam, colposcopy and biopsy (if indicated) per protocol
• Able/willing to complete Study Diary
• Agree to abstain from sexual intercourse for 48 hours prior to the enrollment visit
• Agree to apply assigned study gel as required per protocol
• Agree to abstain from the following activities from at least 48 hours prior to enrollment through the Day 14 visit:
• Insertion of fingers/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

You may not qualify if:

• Are post-menopausal
• Have had a hysterectomy
• Clinically significant chronic medical condition (other than HIV) that is considered progressive.
• History of malignancy, with the exception of basal cell or squamous cell skin cancer
• Pregnant or planning to become pregnant in the next three months
• Currently breastfeeding
• History of sensitivity or allergy to latex or any compound used in this study
• Have received antibiotics in the 14 days prior to enrollment
• Have used a spermicide or spermicidally lubricated condom within 7 days prior to enrollment
• Have been using a hormonal contraceptive method for less than 3 months prior to enrollment
• Have participated in other microbicide or contraceptive studies in the past three months
• Grade 3 or higher liver, renal or hematology abnormality, as defined by the Table for Grading the Severity of Adult Adverse Events at screening
• Have a positive bacterial urine culture
• Currently have a clinically detectable genital abnormality (i.e. vulvar, vaginal, cervical and/or perineal ulcer or lesions or abnormal Pap smear)
• In the three months prior to enrollment have had any of the following:

Sponsors & Collaborators

• CONRAD: lead
• Emory University: collaborator
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

Hope Clinic of Emory University

Decatur, Georgia, 30030, United States

Location

MeSH Terms

Conditions

HIV Infections

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

• Kimberly Workowski, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 11, 2005
• First Posted: August 22, 2005
• Study Start: October 1, 2005
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: January 7, 2010

Record last verified: 2010-01

Locations

US (1)