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

May 1, 2009 updated by: University of California, Los Angeles

A Phase 1 Randomized, Blinded, Placebo-Controlled Safety and Acceptability Study of the UC-781 Vaginal Microbicide Gel Formulation Applied Rectally in HIV-1 Seronegative Adults

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to obtain preliminary data on the safety and acceptability of UC-781 vaginal microbicide gel (0.1% and 0.25%) versus placebo when rectally administered in HIV-1 seronegative adults.

Participants will enter a screening period, which includes Visit 1 and if necessary a medication washout period.

Subjects who are deemed eligible after this screening period will return for a baseline evaluation (Visit 2), including clinical evaluation and mucosal specimen collection, as well as the Baseline Behavioral Questionnaire (BBQ). The BBQ will be administered by Computer Assisted Self-Interview (CASI). Subjects may complete the web-based CASI in the privacy of their own home. If a subject does not have access to the Internet, prefers to complete the BBQ at the study site, or requires assistance in using the CASI, he or she will be accommodated at the study site.

After completing Visits 1 and 2, eligible subjects will be randomized to one of three groups: 0.1% UC-781 gel, 0.25% UC-781 gel, or a placebo gel (12 per group). A subset of 9 subjects (3 from each group) will also participate in a pK sub-study, which will include 6 timepoints (Visit 3- pre, 0.25 hr, 2 hr, 4 hr, Visit 3A- 24 hr, and Visit 5- 1 day post-QD dose). During randomization, study staff will be notified if the participant is randomized to the pK substudy.

This study will involve 2 stages of treatment. Each treatment stage is independent of the other. This study aims to examine the effects of 2 different dosing regimens, NOT cumulative safety over the both stages.

Once randomized, subjects will return to the clinic (Visit 3), where a single dose of the study gel (Treatment Stage 1) will be administered followed by clinical evaluation, including flexible sigmoidoscopy, and sample collection.

Subjects will return to the clinic for Treatment Stage 2 Clearance (Visit 4), in the week prior to beginning Treatment Stage 2. If given clearance, the subject may begin Treatment Stage 2.

In Treatment Stage 2, subjects will begin to self-administer once daily outpatient doses of the study gel for 7 days. After completion of Stage 2 the subject will complete a Product Acceptability Questionnaire (PAQ) by CASI and return to clinic for evaluation and specimen collection (Visit 5).

After completion of Visit 5, subjects will be contacted by an interviewer to complete an in-depth phone interview regarding product acceptability.

Study Type

Interventional

Enrollment (Anticipated)

36

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90024
        • UCLA Center for HIV Prevention Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

Men who meet the following 10 criteria and women who meet the following 12 criteria are eligible for inclusion in the study:

  1. ≥ Age of 18
  2. HIV-1 status antibody negative as documented at screening
  3. Understands and agrees to local STI reporting requirements
  4. Able and willing to communicate in English
  5. Able and willing to provide written informed consent
  6. Able and willing to provide adequate information for locator purposes
  7. Availability to return for all study visits

  8. A history of consensual RAI at least once in lifetime:

    • Required to assure that subjects have a context for the acceptability assessments
  9. 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

  10. 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:

  11. Negative pregnancy test
  12. 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.

Exclusion Criteria:

Individuals who meet any of the following criteria at screening will be excluded from the study:

  1. HIV positive at baseline
  2. History of inflammatory bowel disease
  3. Active inflammatory condition of the GI tract at baseline
  4. Active rectal infection at baseline
  5. ≥ Grade 2 laboratory abnormality (≥ Grade 1 potassium, magnesium, chloride, sodium, and calcium) at baseline
  6. History of an underlying cardiac arrhythmia or renal disease that may be exacerbated by electrolyte abnormalities
  7. History of severe or recent cardiac or pulmonary event
  8. History of a large aortic aneurysm
  9. History of significant gastrointestinal bleeding
  10. Allergy to methylparaben, propylparaben, sorbic acid
  11. History of alcoholism or IV drug abuse
  12. Unwillingness to refrain from chronic use of aspirin and NSAIDs
  13. Use of warfarin or heparin
  14. Use of systemic immunomodulatory medications within 4 weeks of Visit 2
  15. Use of rectally administered medications, with the exception of over-the-counter enemas, within 4 weeks of Visit 2
  16. Use of product containing nonoxyl-9 rectally within 4 weeks of Visit 2
  17. Use of any investigational products within 4 weeks of Visit 2

  18. Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study or unable to comply with the study requirements. Such conditions may include, but are not limited to, current or recent history of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, or cerebral disease.

    In addition to the criteria listed above, female participants will be excluded if the meet any of the following criteria:

  19. Pregnancy
  20. Breastfeeding
  21. Female of child-bearing potential unwilling to use acceptable form of contraception

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Frequency of ≥ Grade 2 adverse events
Acceptability assessments

Secondary Outcome Measures

Outcome Measure
Epithelial sloughing
Histopathology
Microflora
Mucosal mononuclear cell phenotype
Mucosal cytokine profile
Mucosal immunoglobulins
Fecal calprotectin
Explants- Mucosal cytokine profile and susceptibility to HIV infection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Los Angeles

Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)
CONRAD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Study Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

December 6, 2006

First Submitted That Met QC Criteria

December 6, 2006

First Posted (Estimate)

December 7, 2006

Study Record Updates

Last Update Posted (Estimate)

May 4, 2009

Last Update Submitted That Met QC Criteria

May 1, 2009

Last Verified

May 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U19-AI060614:P4 Aim 1
  • 06-04-043

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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