Abstract

You are being asked to take part in a research study of a new product called PMPA vaginal gel. The scientific name for PMPA is 9-[(R)-2-(phosphonomethoxy)propyl]adenine monohydrate. PMPA gel was made to see if it can prevent women from becoming infected with HIV, the virus that causes AIDS, through sex. Before studying whether PMPA gel prevents people from getting HIV, we must make sure that is safe for women to use. PMPA has been used safely in a small number of people given either orally (my mouth) or intravenously (IV through an arm vein). PMPA gel has not been tested in the vaginas of women. Up to 70 women will participate in this safety study. This study is being done in Philadelphia and Providence, Rhode Island. This research study includes 4 visits. These visits include a screening visit, an enrollment visit, a day 7 visit, and a day 14 visit. In addition, you may be asked to participate in a focus group visit. The tests and exams from the screening visit and the enrollment visit will determine if you can be in the study.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000040-40
Application #
6414379
Study Section
National Center for Research Resources Initial Review Group (RIRG)
Project Start
1974-10-01
Project End
2002-11-30
Budget Start
Budget End
Support Year
40
Fiscal Year
2000
Total Cost
Indirect Cost

  Institution

Name
University of Pennsylvania
Department
Type
DUNS #
042250712
City
Philadelphia
State
PA
Country
United States
Zip Code
19104

  Publications

Khalili, Mandana; Shuhart, Margaret C; Lombardero, Manuel et al. (2018) Relationship Between Metabolic Syndrome, Alanine Aminotransferase Levels, and Liver Disease Severity in a Multiethnic North American Cohort With Chronic Hepatitis B. Diabetes Care 41:1251-1259
Thomas, Bernadette; Matsushita, Kunihiro; Abate, Kalkidan Hassen et al. (2017) Global Cardiovascular and Renal Outcomes of Reduced GFR. J Am Soc Nephrol 28:2167-2179
Ojiro, Keisuke; Qu, Xiaowang; Cho, Hyosun et al. (2017) Modulation of Hepatitis C Virus-Specific CD8 Effector T-Cell Function with Antiviral Effect in Infectious Hepatitis C Virus Coculture Model. J Virol 91:
Di Bisceglie, A M; Lombardero, M; Teckman, J et al. (2017) Determination of hepatitis B phenotype using biochemical and serological markers. J Viral Hepat 24:320-329
Lok, A S; Ganova-Raeva, L; Cloonan, Y et al. (2017) Prevalence of hepatitis B antiviral drug resistance variants in North American patients with chronic hepatitis B not receiving antiviral treatment. J Viral Hepat 24:1032-1042
Leonard, Mary B; Shults, Justine; Long, Jin et al. (2016) Effect of Low-Magnitude Mechanical Stimuli on Bone Density and Structure in Pediatric Crohn's Disease: A Randomized Placebo-Controlled Trial. J Bone Miner Res 31:1177-88
Ricordi, Camillo; Goldstein, Julia S; Balamurugan, A N et al. (2016) National Institutes of Health-Sponsored Clinical Islet Transplantation Consortium Phase 3 Trial: Manufacture of a Complex Cellular Product at Eight Processing Facilities. Diabetes 65:3418-3428
Evon, Donna M; Wahed, Abdus S; Johnson, Geoffrey et al. (2016) Fatigue in Patients with Chronic Hepatitis B Living in North America: Results from the Hepatitis B Research Network (HBRN). Dig Dis Sci 61:1186-96
Park, Jang-June; Wong, David K; Wahed, Abdus S et al. (2016) Hepatitis B Virus--Specific and Global T-Cell Dysfunction in Chronic Hepatitis B. Gastroenterology 150:684-695.e5
Hering, Bernhard J; Clarke, William R; Bridges, Nancy D et al. (2016) Phase 3 Trial of Transplantation of Human Islets in Type 1 Diabetes Complicated by Severe Hypoglycemia. Diabetes Care 39:1230-40

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