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Dapivirine Gel Rectal Safety and PK Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03044379
Recruitment Status : Withdrawn (Current program is on hold, not for safety reason)
First Posted : February 7, 2017
Last Update Posted : February 8, 2017
Sponsor:
Information provided by (Responsible Party):
International Partnership for Microbicides, Inc.

Brief Summary:
Dapivirine Gel Rectal Safety and PK Study

Condition or disease Intervention/treatment Phase
HIV 1 Infection Drug: Dapivirine gel (0.05%) Other: Universal HEC placebo gel Phase 1

Detailed Description:
A Randomized, Double Blind, Placebo-Controlled Phase 1 Safety and Pharmacokinetic Study of Dapivirine Gel (0.05%) Administered Rectally to HIV-1 Seronegative Adults

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: A Randomized, Double Blind, Placebo-Controlled, Phase 1 Safety and Pharmacokinetic Study of Dapivirine Gel (0.05%) Administered Rectally to HIV-1 Seronegative Adults
Actual Study Start Date : September 29, 2015
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : November 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Active Comparator: Dapivirine Gel
Participants will be randomized to receive a single dose of dapivirine gel rectally, followed by 7 daily doses of the same product to be administered under direct observation in the clinic.
Drug: Dapivirine gel (0.05%)
MTN-026/IPM 038 will use the HTI pre-filled applicator, the same applicator that has been utilized in other rectal studies.

Placebo Comparator: Placebo Gel HEC
Participants will be randomized to receive the universal HEC placebo gel rectally, followed by 7 daily doses of the same product to be administered under direct observation in the clinic.
Other: Universal HEC placebo gel



Primary Outcome Measures :
  1. Safety To characterize the systemic and compartmental pharmacokinetics of dapivirine gel following rectal application. [ Time Frame: 9-12 months ]
    To evaluate the safety of dapivirine gel formulation when applied rectally.


Secondary Outcome Measures :
  1. Acceptability [ Time Frame: 9-12 months ]
    To identify product attributes considered likely to challenge and facilitate future sustained use of rectally applied dapivirine gel.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age of 18 - 45 years (inclusive), verified per site SOP
  • Able and willing to provide written informed consent
  • HIV-1/2 uninfected at Screening and Enrollment, per applicable algorithm in Appendix II and willing to receive HIV test results
  • Able and willing to provide adequate locator information, as defined in site SOP
  • Available to return for all study visits and willing to comply with study participation requirements
  • In general good health at Screening and Enrollment, as determined by the site IoR or designee
  • Per participant report, a history of consensual RAI at least once in the past calendar year
  • Willing to not take part in other research studies involving drugs, medical devices, genital products, or vaccines for the duration of study participation, including the time between Screening and Enrollment

Exclusion Criteria: At Screening:

  • Hemoglobin Grade 1 or higher*
  • Platelet count Grade 1 or higher*
  • White blood count Grade 2 or higher*
  • Serum creatinine 1.3 the site laboratory upper limit of normal (ULN)
  • International normalized ratio (INR) 1.5 the site laboratory ULN
  • Aspartate aminotransferase (AST) or alanine transaminase (ALT) Grade 1 or higher*
  • Positive for hepatitis C antibody
  • Positive for hepatitis B surface antigen
  • History of inflammatory bowel disease by participant report

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03044379


Locations
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United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
International Partnership for Microbicides, Inc.

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Responsible Party: International Partnership for Microbicides, Inc.
ClinicalTrials.gov Identifier: NCT03044379    
Other Study ID Numbers: MTN-026/ IPM 038
First Posted: February 7, 2017    Key Record Dates
Last Update Posted: February 8, 2017
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Dapivirine
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents