Male Tolerance Study of Dapivirine Gel Following Multiple Topical Penile Exposures

NCT01277640 | Completed Phase 1 DMC

• 1 other identifier: MTN-012/IPM 010
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Topical Penile Exposures

Keywords

male tolerance; HIV-1; microbicide; dapivirine

Outcome Measures

Primary Outcomes (1)

• 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).

  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)

  8 days

Secondary Outcomes (3)

• To assess the pharmacokinetics in plasma following 7 days of once daily penile application of dapivirine gel (0.05%)

  8 days

• To assess the systemic safety following 7 days of once daily penile application of dapivirine gel (0.05%)

  8 days

• To assess the acceptability following 7 days of once daily penile application of dapivirine gel (0.05%)

  8 days

Study Arms (3)

matched placebo

PLACEBO COMPARATOR

Drug: matched placebo

universal placebo

PLACEBO COMPARATOR

Drug: universal placebo

dapivirine

ACTIVE COMPARATOR

Drug: dapivirine

Interventions

dapivirine DRUG

* dosage form: gel 0.05% * dosage: 2.5g * frequency: once daily * duration: 7 days

dapivirine

matched placebo DRUG

* dosage form: gel, no api * dosage: 2.5g * frequency: once daily * duration: 7 days

matched placebo

universal placebo DRUG

* dosage form: gel, HEC-based * dosage: 2.5g * frequency: once daily * duration: 7 days

universal placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• International Partnership for Microbicides, Inc.: lead

Study Sites (2)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

• Cranston RD, Hoesley C, Carballo-Dieguez A, Hendrix CW, Husnik M, Levy L, Hall W, Soto-Torres L, Nel AM. A randomized male tolerance study of dapivirine gel following multiple topical penile exposures (MTN 012/IPM 010). AIDS Res Hum Retroviruses. 2014 Feb;30(2):184-9. doi: 10.1089/AID.2013.0170. Epub 2013 Oct 26.

  PMID: 24070431 RESULT

MeSH Terms

Interventions

Dapivirine

Study Officials

• Ross D. Cranston, MD, FRCP

  Division of Infectious Diseases, University of Pittsburgh Medical Center

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: January 13, 2011
• First Posted: January 17, 2011
• Study Start: March 1, 2011
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: September 8, 2017

Record last verified: 2017-09

Locations

US (2)