A Phase I Pharmacokinetics and Safety Study of Two Dapivirine Intravaginal Gels - Full Text View

Purpose

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.

Condition	Intervention	Phase
HIV Infections	Drug: Dapivirine Gel 4750, 0.05%, 2.5g Drug: Dapivirine Gel 4789, 0.05%, 2.5g Drug: HEC-based Placebo Gel	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Official Title:	A Double-Blind, Randomized, Placebo-Controlled Phase I Study to Compare the Pharmacokinetics of Intravaginal Dapivirine Gel 4750, 0.05%, 2.5g and Dapivirine Gel 4789, 0.05%, 2.5g Formulations and to Assess the Safety as Compared to the Intravaginal HEC-Based Universal Placebo Gel, 2.5g in Healthy HIV-Negative Women.

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Further study details as provided by International Partnership for Microbicides, Inc.:

Primary Outcome Measures:

Serial dapivirine concentrations in plasma, vaginal fluid and cervical-vaginal tissue samples [ Time Frame: 11 days ] [ Designated as safety issue: No ]
Self-reported genital symptoms, pelvic/colposcopic exam findings, laboratory evaluations and adverse events/serious adverse events [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Enrollment:	36
Study Start Date:	November 2007
Study Completion Date:	March 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A	Drug: Dapivirine Gel 4750, 0.05%, 2.5g intravaginal gel, dosed daily
Experimental: B	Drug: Dapivirine Gel 4789, 0.05%, 2.5g intravaginal gel, dosed daily
Placebo Comparator: C	Drug: HEC-based Placebo Gel intravaginal gel, dosed daily

Eligibility

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00613249

Locations

Belgium
SGS Life Science Services Research Unit Stuivenberg
Antwerp, Belgium, B-2060

Sponsors and Collaborators

International Partnership for Microbicides, Inc.

Investigators

Study Director:

Dr. Annalene Nel

IPM

More Information

Publications:

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

Responsible Party:	Dr. Annalene Nel, International Partnership for Microbicides
ClinicalTrials.gov Identifier:	NCT00613249 History of Changes
Other Study ID Numbers:	IPM 012
Study First Received:	January 31, 2008
Last Updated:	March 26, 2009
Health Authority:	Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by International Partnership for Microbicides, Inc.:

HIV-1 Infection
HIV Seronegativity

Additional relevant MeSH terms:

HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases

Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on May 16, 2013