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?
- 18 -45 year old women
- normal Pap smear
- not pregnant
- abnormal pelvic exam
- history of claustrophobia
- allergy to product formulation
- pregnant or breastfeeding
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
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
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.
Start Date: June 2005
Phase: Phase 1
Primary Outcome: Presence or absence of bare spots with and without Gd.
Study sponsors, principal investigator, and references
Principal Investigator: Kurt Barnhart, MD
Lead Sponsor: Biosyn
Collaborator: National Institute of Allergy and Infectious Diseases (NIAID)