Phase I Study of Safety and Persistence of UC-781 Vaginal Microbicide

NCT00441909 | Completed Phase 1

• 1 other identifier: U19AI051661
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Vaginal microbicides are compounds that may protect women from HIV and other sexually transmitted infections (STIs). This study will determine the safety of the microbicide UC-781 by comparing the effects of keeping the microbicide in the vagina for different lengths of time.

Conditions

HIV Infections

Keywords

Anti-Infective Agents, Local; Healthy Women; Microbicides; UC-781; Vaginal Gel; HIV Seronegativity

Outcome Measures

Primary Outcomes (1)

• Local and systemic safety of a one-time dose of UC-781 0.1 % gel for vaginal use at different durations of exposure in HIV uninfected women

  Throughout study

Secondary Outcomes (6)

• Persistence of UC-781 0.1% gel following a single application

  At 0, 2, 4, or 8 hours post application

• Systemic absorption of UC-781 following a single application of 0.1% UC-781 gel

  At 0, 2, 4, or 8 hours post application

• In vitro anti-HIV activity of cervicovaginal lavage fluid

  Throughout study

• Product acceptability

  Throughout study

• Measurement of vaginal flora characteristics

  Throughout study

Study Arms (8)

1A

EXPERIMENTAL

Participants will receive a single application of UC-781 vaginal microbicide, which will be inserted for 8 hours

Drug: UC-781

1B

PLACEBO COMPARATOR

Participants will receive a single application of UC-781 vaginal microbicide placebo, which will be inserted for 8 hours

Drug: UC-781 placebo

2A

EXPERIMENTAL

Participants will receive a single application of UC-781 vaginal microbicide, which will be inserted for 4 hours

Drug: UC-781

2B

PLACEBO COMPARATOR

Participants will receive a single application of UC-781 vaginal microbicide placebo, which will be inserted for 4 hours

Drug: UC-781 placebo

3A

EXPERIMENTAL

Participants will receive a single application of UC-781 vaginal microbicide, which will be inserted for 2 hours

Drug: UC-781

3B

PLACEBO COMPARATOR

Participants will receive a single application of UC-781 vaginal microbicide placebo, which will be inserted for 2 hours

Drug: UC-781 placebo

4A

EXPERIMENTAL

Participants will receive a single application of UC-781 vaginal microbicide, which will be inserted for 0 hours

Drug: UC-781

4B

PLACEBO COMPARATOR

Participants will receive a single application of UC-781 vaginal microbicide placebo, which will be inserted for 0 hours

Drug: UC-781 placebo

Interventions

UC-781 DRUG

0.1% UC-781 Vaginal Gel

1A; 2A; 3A; 4A

UC-781 placebo DRUG

Vaginal Gel Placebo

1B; 2B; 3B; 4B

Eligibility Criteria

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

You may qualify if:

• HIV uninfected
• General good health
• Normal Pap smear within 12 months prior to screen or obtained at screening visit
• Anatomy that lends itself easily to visualization of the cervix
• Sexual abstinence (including vaginal, oral, and rectal) from Visit 1 to the completion of Visit 4
• Agree to use condoms provided by the study between Visits 4 and 5
• Agree to abstain from the use of intravaginal products or vaginal penetration throughout the study
• Willing to use acceptable forms of contraception until the completion of study
• Willing to participate in all study-related assessments and follow all study-related procedures
• Willing to stay in the Magee-Womens Hospital Clinical Research Center (MWH CRC) for up to 9 hours after gel insertion

You may not qualify if:

• Menopause (at least 12 months without menses in absence of long-acting progestin use)
• Hysterectomy
• Latex allergy
• Use of a diaphragm, NuvaRing, or spermicide for contraception
• Diagnosed urogenital infection or suspected infection 21 days prior to study screening. More information on this criterion can be found in the protocol.
• Menses or other vaginal bleeding anticipated in the 17 days postscreening
• Antibiotic or antifungal therapy (vaginal or systemic) 14 days prior to study screening
• Injected nontherapeutic drugs 12 months prior to study screening
• Systemic immunosuppressive drug use 60 days prior to study screening
• Participation in drug, spermicide, and/or microbicide study 30 days prior to study screening
• Any condition that, in the opinion of the investigator, would interfere with the study
• Intravaginal use of any device or product (except tampons) 7 days prior to study screening
• Surgical procedure involving the pelvis in the 90 days prior to enrollment (e.g., dilation and curettage or evacuation, cervical biopsy, cryosurgery,any other surgery involving pelvic organs or area)
• Abnormal pelvic exam finding that, in the opinion of the investigator would complicate interpretation of the colposcopy
• Pregnancy, or within 90 days of last pregnancy

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• CONRAD: collaborator

Study Sites (1)

Magee-Womens Hospital of University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Location

Related Publications (5)

• Davis CW, Doms RW. HIV transmission: closing all the doors. J Exp Med. 2004 Apr 19;199(8):1037-40. doi: 10.1084/jem.20040426. Epub 2004 Apr 12. No abstract available.

  PMID: 15078894 BACKGROUND

• Joshi S, Solomon S, Mayer K, Mehendale S. Preparing for efficacy trials of vaginal microbicides in Indian women. Indian J Med Res. 2005 Apr;121(4):502-9.

  PMID: 15817959 BACKGROUND

• Keller MJ, Tuyama A, Carlucci MJ, Herold BC. Topical microbicides for the prevention of genital herpes infection. J Antimicrob Chemother. 2005 Apr;55(4):420-3. doi: 10.1093/jac/dki056. Epub 2005 Mar 2.

  PMID: 15743896 BACKGROUND

• Minnis AM, Padian NS. Effectiveness of female controlled barrier methods in preventing sexually transmitted infections and HIV: current evidence and future research directions. Sex Transm Infect. 2005 Jun;81(3):193-200. doi: 10.1136/sti.2003.007153.

  PMID: 15923284 BACKGROUND

• Weber J, Desai K, Darbyshire J; Microbicides Development Programme. The development of vaginal microbicides for the prevention of HIV transmission. PLoS Med. 2005 May;2(5):e142. doi: 10.1371/journal.pmed.0020142. Epub 2005 May 31.

  PMID: 15916473 BACKGROUND

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

• Sharon L. Hillier, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

• Harold C. Wiesenfeld, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 27, 2007
• First Posted: March 1, 2007
• Study Start: April 1, 2006
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: March 5, 2009

Record last verified: 2009-03

Locations

US (1)