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HIV Infections | An Imaging Trial of the Distribution of Topical Gel in the Human Vagina: Assessment of Bare Spots

HIV Infections research study

What is the primary objective of this study?

This study will assess the distribution of a microbicidal gel in the vagina and confirm the presence of bare spots. MRIs will be done with and without the addition of the MRI contrast Gadolinium to the microbicide in order to determine whether the bare spots are an artifact of the MRI technique.

Who is eligible to participate?

Inclusion Criteria: - 18 -45 year old women - normal Pap smear - not pregnant Exclusion Criteria: - abnormal pelvic exam - history of claustrophobia - allergy to product formulation - pregnant or breastfeeding

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

HIV Infections

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:HEC placebo gel

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Study Status

Unknown status

Start Date: June 2005

Completed Date:

Phase: Phase 1

Type: Interventional

Design:

Primary Outcome: Presence or absence of bare spots with and without Gd.

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Kurt Barnhart, MD

Lead Sponsor: Biosyn

Collaborator: National Institute of Allergy and Infectious Diseases (NIAID)

More information:https://clinicaltrials.gov/show/NCT00214812

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