A Safety Study of Dapivirine (TMC120) Vaginal Microbicide Gel in South Africa

NCT00304668 | Withdrawn Phase 1

• 1 other identifier: IPM005A
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Approximately 42 HIV-negative women, aged \>18 and \< 50, will be enrolled in this study. Each volunteer will have a 2:1 chance of receiving Dapivirine Gel-002 versus placebo. The volunteers will receive investigational product for a total of 42 days.

Conditions

HIV Infections

Keywords

HIV-1; HIV Seronegativity

Outcome Measures

Primary Outcomes (1)

• Local and systemic safety and tolerability.

Interventions

dapivirine (TMC120) vaginal gel DRUG

Eligibility Criteria

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

You may qualify if:

• HIV-negative
• Willing to participate and sign an informed consent form
• Willing to be tested for HIV, use an experimental vaginal gel, and to be randomized to a study group that includes the possibility of being assigned to a placebo group.
• Willing to use two forms of contraception during the study
• Willing to undergo pelvic examinations with colposcopy and photographic documentation according to the protocol throughout the study.
• Have a regular menstrual cycle defined as having a minimum of 21 days and a maximum of 36 days between menses

You may not qualify if:

• Currently pregnant or breast-feeding
• Clinically detectable genital abnormality on the vulva, vaginal walls or cervix
• Laboratory confirmed gonorrhea, chlamydia, trichomonas, syphilis, or vaginal candidiasis or clinically diagnosed GUD or active HSV-2 lesion
• Breakthrough bleeding or gynecologic surgery within 60 days prior to randomization
• Symptomatic bacterial vaginosis at Screening and unwilling to undergo treatment.
• Women who require treatment for tuberculosis (TB) within 21 days prior to randomization.

Sponsors & Collaborators

• International Partnership for Microbicides, Inc.: lead

MeSH Terms

Conditions

HIV Infections

Interventions

Dapivirine; Vaginal Creams, Foams, and Jellies

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

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations; Feminine Hygiene Products; Equipment and Supplies

Study Officials

• Zeda Rosenberg, ScD

  Beijing Immupeutics Medicine Technology Limited

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: March 17, 2006
• First Posted: March 20, 2006
• Last Updated: December 10, 2015

Record last verified: 2006-05