Male Tolerance Study of Dapivirine Gel Following Multiple Topical Penile Exposures

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
International Partnership for Microbicides, Inc.
ClinicalTrials.gov Identifier:
NCT01277640
First received: January 13, 2011
Last updated: September 9, 2011
Last verified: September 2011
  Purpose

The purpose of this study is to determine the safety of male genitalia when exposed to dapivirine gel following seven once daily applications.


Condition Intervention Phase
Topical Penile Exposures
Drug: dapivirine
Drug: matched placebo
Drug: universal placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Male Tolerance Study of Dapivirine Gel Following Multiple Topical Penile Exposures

Resource links provided by NLM:


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

Primary Outcome Measures:
  • To determine the genitourinary safety of dapivirine gel (0.05%), the endpoint was the proportion of men subjected to dapivirine gel or placebo gel experiencing specific, protocol-defined safety events during the study (see description). [ Time Frame: 8 days ] [ Designated as safety issue: Yes ]
    Any evidence of Grade 2 or higher male genitourinary adverse event(s) as defined by the DAIDS AE Grading Table Version 1.0, December 2004 (Clarification dated August 2009), Addendum 2 (Male Genital Toxicity Table for Use in Topical Microbicide Studies)


Secondary Outcome Measures:
  • To assess the pharmacokinetics in plasma following 7 days of once daily penile application of dapivirine gel (0.05%) [ Time Frame: 8 days ] [ Designated as safety issue: No ]
    Dapivirine concentrations in blood

  • To assess the systemic safety following 7 days of once daily penile application of dapivirine gel (0.05%) [ Time Frame: 8 days ] [ Designated as safety issue: Yes ]
    Grade 2 and higher clinical and laboratory adverse events as defined by the DAIDS AE Grading Table Version 1.0, December 2004 (Clarification dated August 2009) and the Male Genital Toxicity Table for Use in Topical Microbicide Studies

  • To assess the acceptability following 7 days of once daily penile application of dapivirine gel (0.05%) [ Time Frame: 8 days ] [ Designated as safety issue: No ]
    Proportion of participants who at their Final Clinic Visit report via the acceptability questionnaire, that they would be very likely to use the candidate microbicide during sexual intercourse in the future


Enrollment: 48
Study Start Date: March 2011
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: matched placebo Drug: matched placebo
  • dosage form: gel, no api
  • dosage: 2.5g
  • frequency: once daily
  • duration: 7 days
Placebo Comparator: universal placebo Drug: universal placebo
  • dosage form: gel, HEC-based
  • dosage: 2.5g
  • frequency: once daily
  • duration: 7 days
Active Comparator: dapivirine Drug: dapivirine
  • dosage form: gel 0.05%
  • dosage: 2.5g
  • frequency: once daily
  • duration: 7 days

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • At least 18 years of age at Screening, verified per site standard operating procedure (SOP)
  • Able and willing to provide written informed consent to be screened for and take part in the study
  • At Screening, able and willing to provide adequate locator information, as defined per site SOP
  • Able and willing to communicate in written and spoken English
  • HIV-uninfected at Screening per Algorithm in Appendix II
  • In general good health, according to the clinical judgment of the Investigator of Record (IoR) or designee
  • Willing to abstain from vaginal, oral and anal intercourse (including receptive anal intercourse), even with a condom; masturbation, and other activities that may cause irritation or injury to the penis during study participation
  • Willing to abstain from using any genitally-applied preparations (except use of usual cleansing products for genital hygiene) other than the study product during study participation
  • Willing to abstain from non-urgent surgical procedures of the penis/GU area for the duration of study participation (e.g. circumcision)
  • At Screening and Enrollment, agrees not to participate in other research studies involving drugs, medical devices, or genital products for the duration of study participation (until all follow-up visits are completed)

Exclusion Criteria:

  • Participant report of any of the following:

    • Known adverse reaction to any of the study products or components of the study products (ever)
    • Post-exposure prophylaxis (PEP) for HIV exposure within 6 months prior to Enrollment
    • Penile procedures (e.g. biopsy, circumcision) within 42 days or less prior to Enrollment
    • Participation in any other research study involving drugs, medical devices, or genital products within 30 days or less prior to Enrollment
    • Within the three months prior to Enrollment, history of a non-gonococcal urethritis and/or sexually transmitted infection (STI), including outbreak of genital herpes or condylomata
    • For uncircumcised men, the treatment of candidal balanoposthitis/ balanitis within 30 days prior to Enrollment
    • History of recurrent dermatosis (e.g. eczema)
    • Non-therapeutic injection drug use in the 12 months prior to Screening
    • Currently using an immunosuppressant (with the exception of local nongenital use of low potency products e.g. inhaled corticosteroid for asthma)
    • Has any of the following laboratory abnormalities at Screening:

      • Hemoglobin < 10.0 g/dL
      • Platelet count < 100,000/mm3
      • White blood cell count < 2,000 cells/mm3
      • Alanine transaminase (ALT) and/or aspartate aminotransferase (AST) > 2.5x the site laboratory upper limit of normal (ULN)
      • Serum creatinine > 1.3x the site laboratory ULN
      • Calculated creatinine clearance less than 80 mL/min by the Cockcroft-Gault formula where creatinine clearance in mL/min = (140-age in years) x (weight in kg) x 0.85/72 x serum creatinine in mg/dL Note: Otherwise eligible participants with any of the above exclusionary laboratory results may be re-tested. If a participant is re-tested and a non exclusionary result is documented within 30 days of providing informed consent for Screening, the participant may be enrolled.
  • At Screening or Enrollment, diagnosed with STI or reproductive tract infection (RTI) requiring treatment, per current Centers for Disease Control and Prevention (CDC) guidelines
  • At Screening or Enrollment, has a clinically apparent Grade 1 or higher genital exam finding (observed by study staff)
  • At Screening or Enrollment, has Grade 1 or higher genital or urinary symptoms
  • At Screening or Enrollment, diagnosed with phimosis or hypospadias
  • At Screening or Enrollment, penile, scrotal piercing or penile tattoos observed during genital examination
  • Has any other condition that, in the opinion of the IoR/designee, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01277640

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
International Partnership for Microbicides, Inc.
Investigators
Study Chair: Ross D. Cranston, MD, FRCP Division of Infectious Diseases, University of Pittsburgh Medical Center
  More Information

No publications provided

Responsible Party: International Partnership for Microbicides, Inc.
ClinicalTrials.gov Identifier: NCT01277640     History of Changes
Other Study ID Numbers: MTN-012/IPM 010
Study First Received: January 13, 2011
Last Updated: September 9, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by International Partnership for Microbicides, Inc.:
male tolerance
HIV-1
microbicide
The study will assess the safety and tolerability of dapivirine when applied topically to the penis of healthy, HIV-uninfected, adult males, both circumcised
and uncircumcised

ClinicalTrials.gov processed this record on July 28, 2014