A Phase I Pharmacokinetics and Safety Study of Two Dapivirine Intravaginal Gels

NCT00613249 | Completed Phase 1

• 1 other identifier: IPM 012
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

IPM 012 is a double-blind, randomized, placebo-controlled phase I study conducted at one research center in Belgium among 36 healthy, HIV-negative women of 18-40 years of age, randomized in a 1:1:1 ratio to assess plasma, vaginal fluid and vaginal tissue levels and the pharmacokinetics of dapivirine when applying either Dapivirine Gel 4750, 0.05%, 2.5g or Dapivirine Gel 4789, 0.05%, 2.5g intravaginally for 11 days (1 day followed by a 3 day washout period and then 10 consecutive days); and to assess the safety of these gels as compared to the intravaginal HEC-based universal placebo gel.

Conditions

HIV Infections

Keywords

HIV-1 Infection; HIV Seronegativity

Outcome Measures

Primary Outcomes (2)

• Serial dapivirine concentrations in plasma, vaginal fluid and cervical-vaginal tissue samples

  11 days

• Self-reported genital symptoms, pelvic/colposcopic exam findings, laboratory evaluations and adverse events/serious adverse events

  14 days

Study Arms (3)

A

EXPERIMENTAL

Drug: Dapivirine Gel 4750, 0.05%, 2.5g

B

EXPERIMENTAL

Drug: Dapivirine Gel 4789, 0.05%, 2.5g

C

PLACEBO COMPARATOR

Drug: HEC-based Placebo Gel

Interventions

Dapivirine Gel 4750, 0.05%, 2.5g DRUG

intravaginal gel, dosed daily

A

Dapivirine Gel 4789, 0.05%, 2.5g DRUG

intravaginal gel, dosed daily

B

HEC-based Placebo Gel DRUG

intravaginal gel, dosed daily

C

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women between 18 and 40 years of age, inclusive
• Willing and able to give written informed consent
• Available for all visits and consent to follow all procedures
• Healthy, based on medical history, vital signs, physical examination, urinalysis, laboratory evaluations for genital infections and laboratory evaluations for hematology, liver and renal function
• HIV-negative as determined by a HIV-1 ELISA test at enrollment
• Willing to abstain from sexual activity for the duration of the study
• On stable oral contraceptive regimen for 2 months prior to enrollment and willing to continue
• Upon pelvic/speculum examination, the cervix and vagina appear normal
• Willing to refrain from the use of vaginal products from 14 days prior to enrollment and for the duration of the study

You may not qualify if:

• History of alcoholism, drug abuse, psychosis, antagonistic personality, poor motivation or other emotional or intellectual problems that are likely to invalidate the informed consent process or adversely impact adherence with protocol requirements
• History of sensitivity/allergy to any component of the study product or to latex
• Currently pregnant or breast-feeing, or within 3 months of last pregnancy outcome
• Currently or within one month of participating in any other clinical research study
• History or current diagnosis and/or treatment for a STD within the last three months prior to enrollment
• Current vulvar, vaginal or cervical symptoms/abnormalities as determined by pelvic/speculum exam or colposcopy that could influence the study results
• History of significant urogenital or uterine prolapse, undiagnosed vaginal bleeding or urethral obstruction within the last 3 months
• Current non-iatrogenic pelvic/colposcopic exam findings involving deep epithelial disruption
• Smoking more than 10 cigarettes a day

Sponsors & Collaborators

• International Partnership for Microbicides, Inc.: lead

Study Sites (1)

SGS Life Science Services Research Unit Stuivenberg

Antwerp, B-2060, Belgium

Location

Related Publications (1)

• Nel A, Smythe S, Habibi S, Romano J. 2009. Comparison of Safety and PK of Two Formulations of Dapivirine Vaginal Gel in Healthy, HIV-Negative Women [abstract]. 16th Conference on Retroviruses and Opportunistic Infections; 2009 Feb 8-11; Montreal. Available from: http://www.retroconference.org/2009/PDFs/1065.pdf

  RESULT

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

• Dr. Annalene Nel

  Beijing Immupeutics Medicine Technology Limited

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: January 31, 2008
• First Posted: February 13, 2008
• Study Start: November 1, 2007
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: March 27, 2009

Record last verified: 2009-03

Locations

BE (1)