Safety and Acceptability Study of the UC-781 Microbicide Gel Applied Rectally

NCT00408538 | Completed Phase 1

• 3 other identifiers: U19-AI060614:P4 Aim 106-04-043U19AI060614
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

This study is the first to try this product in the rectum of humans. This study is only to find out if the gel is safe for use in the rectum, not to see if the gel works. Information gathered from this study will help investigators decide whether this gel is safe enough to move onto the next phase of studies. Information gathered from this study will also help investigators determine what participants did and did not like about the product and what types of products people might want to use in the future. Currently condoms and abstinence are the only methods proven to prevent the spread of HIV sexually.

Conditions

HIV Infections

Keywords

Microbicide; HIV; Prevention; Rectal; HIV Prevention

Outcome Measures

Primary Outcomes (2)

• Frequency of ≥ Grade 2 adverse events

• Acceptability assessments

Secondary Outcomes (8)

• Epithelial sloughing

• Histopathology

• Microflora

• Mucosal mononuclear cell phenotype

• Mucosal cytokine profile

Interventions

UC-781 microbicide gel (0.1% and 0.25%) DRUG

placebo DRUG

Eligibility Criteria

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

You may qualify if:

• ≥ Age of 18
• HIV-1 status antibody negative as documented at screening
• Understands and agrees to local STI reporting requirements
• Able and willing to communicate in English
• Able and willing to provide written informed consent
• Able and willing to provide adequate information for locator purposes
• Availability to return for all study visits
• A history of consensual RAI at least once in lifetime:
• Required to assure that subjects have a context for the acceptability assessments
• Willing to abstain from insertion of anything per rectum other than the study gel for the 1 week prior to treatment, 1 week prior each flexible sigmoidoscopy (i.e., during week of study gel use), and 1 week after each flexible sigmoidoscopy
• Must agree to use condoms for the duration of the study
• In addition to the criteria listed above, female participants must meet the following criteria:
• Negative pregnancy test
• Post-menopausal or using an acceptable form of contraception (e.g. barrier method, IUD, hormonal contraception, surgical sterilization, or vasectomization of male partner). If the female subject has female partners only, the method of contraception will be noted as a barrier method in the study documentation.

You may not qualify if:

• Individuals who meet any of the following criteria at screening will be excluded from the study:
• HIV positive at baseline
• History of inflammatory bowel disease
• Active inflammatory condition of the GI tract at baseline
• Active rectal infection at baseline
• ≥ Grade 2 laboratory abnormality (≥ Grade 1 potassium, magnesium, chloride, sodium, and calcium) at baseline
• History of an underlying cardiac arrhythmia or renal disease that may be exacerbated by electrolyte abnormalities
• History of severe or recent cardiac or pulmonary event
• History of a large aortic aneurysm
• History of significant gastrointestinal bleeding
• Allergy to methylparaben, propylparaben, sorbic acid
• History of alcoholism or IV drug abuse
• Unwillingness to refrain from chronic use of aspirin and NSAIDs
• Use of warfarin or heparin
• Use of systemic immunomodulatory medications within 4 weeks of Visit 2

Sponsors & Collaborators

• University of California, Los Angeles: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• CONRAD: collaborator

Study Sites (1)

UCLA Center for HIV Prevention Research

Los Angeles, California, 90024, United States

Location

Related Publications (2)

• Richardson-Harman N, Mauck C, McGowan I, Anton P. Dose-response relationship between tissue concentrations of UC781 and explant infectibility with HIV type 1 in the RMP-01 rectal safety study. AIDS Res Hum Retroviruses. 2012 Nov;28(11):1422-33. doi: 10.1089/AID.2012.0073. Epub 2012 Sep 20.

  PMID: 22900504 DERIVED

• Anton PA, Saunders T, Elliott J, Khanukhova E, Dennis R, Adler A, Cortina G, Tanner K, Boscardin J, Cumberland WG, Zhou Y, Ventuneac A, Carballo-Dieguez A, Rabe L, McCormick T, Gabelnick H, Mauck C, McGowan I. First phase 1 double-blind, placebo-controlled, randomized rectal microbicide trial using UC781 gel with a novel index of ex vivo efficacy. PLoS One. 2011;6(9):e23243. doi: 10.1371/journal.pone.0023243. Epub 2011 Sep 28.

  PMID: 21969851 DERIVED

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 6, 2006
• First Posted: December 7, 2006
• Study Start: December 1, 2006
• Study Completion: April 1, 2008
• Last Updated: May 4, 2009

Record last verified: 2009-05

Locations

US (1)