AzTrials
AzTrials

HIV InfectionsPhase 1NCT00408538

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

A Phase 1 study testing UC-781 microbicide gel (0.1% and 0.25%) in people with HIV Infections, run by University of California, Los Angeles at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
HIV Infections
What is being tested?
UC-781 microbicide gel (0.1% and 0.25%)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
36 participants
Where
1 siteUnited States
Study dates
Dec 2006to Apr 2008
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Men who meet the following 10 criteria and women who meet the following 12 criteria are eligible for inclusion in the study:
  • ≥ 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
Show all 15Show fewer
  • 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.

Who cannot join

  • 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
Show all 23Show fewer
  • 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
  • Use of rectally administered medications, with the exception of over-the-counter enemas, within 4 weeks of Visit 2
  • Use of product containing nonoxyl-9 rectally within 4 weeks of Visit 2
  • Use of any investigational products within 4 weeks of Visit 2
  • 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:
  • Pregnancy
  • Breastfeeding
  • Female of child-bearing potential unwilling to use acceptable form of contraception

Trial locations and contacts

1 site in 1 country.

United States1 site

  • UCLA Center for HIV Prevention Research

    Los Angeles, California, 90024

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions
HIV Infections
Being tested
UC-781 microbicide gel (0.1% and 0.25%), placebo
Keywords
Microbicide, HIV, Prevention, Rectal, HIV Prevention
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • UC-781 microbicide gel (0.1% and 0.25%)Drug

  • placeboDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Frequency of ≥ Grade 2 adverse events

  2. Acceptability assessments

Secondary outcomes (8)

  1. Epithelial sloughing

  2. Histopathology

  3. Microflora

  4. Mucosal mononuclear cell phenotype

  5. Mucosal cytokine profile

  6. Mucosal immunoglobulins

  7. Fecal calprotectin

  8. Explants- Mucosal cytokine profile and susceptibility to HIV infection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Dec 2006 (estimated)
  2. Study startDec 2006
  3. Study completionApr 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00408538
Sponsor's protocol ID
U19-AI060614:P4 Aim 1
Other IDs
06-04-043, U19AI060614
Status last verified
May 2009
First submitted
6 Dec 2006
Last updated
4 May 2009
Results posted
No

Publications

  • 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.

    PubMed 22900504

  • 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.

    PubMed 21969851

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing UC-781 microbicide gel (0.1% and 0.25%) in people with HIV Infections, run by University of California, Los Angeles at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 May 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency of ≥ Grade 2 adverse events. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00408538, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2009.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in