Male Tolerance Study of Dapivirine Gel Following Multiple Topical Penile Exposures

NCT ID: NCT01277640

Last Updated: 2017-09-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2011-07-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

matched placebo

Group Type: PLACEBO_COMPARATOR

matched placebo

Intervention Type: DRUG

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

universal placebo

Group Type: PLACEBO_COMPARATOR

universal placebo

Intervention Type: DRUG

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

dapivirine

Group Type: ACTIVE_COMPARATOR

dapivirine

Intervention Type: DRUG

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

Interventions

dapivirine

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

Intervention Type: DRUG

matched placebo

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

Intervention Type: DRUG

universal placebo

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

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

International Partnership for Microbicides, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ross D. Cranston, MD, FRCP

Role: STUDY_CHAIR

Division of Infectious Diseases, University of Pittsburgh Medical Center

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 24070431 (View on PubMed)

Other Identifiers

MTN-012/IPM 010

Identifier Type: -

Identifier Source: org_study_id