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Sponsored by: |
Elizabeth Glaser Pediatric AIDS Foundation |
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Information provided by: | Elizabeth Glaser Pediatric AIDS Foundation |
ClinicalTrials.gov Identifier: | NCT00639145 |
The purpose of this study is to find out if antiretroviral drugs are safe and well tolerated by HIV-positive pregnant women and their infants in Cote d'Ivoire and Zambia.
Condition |
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HIV Infections HIV Positive Pregnant Women |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Elizabeth Glaser Pediatric AIDS Foundation Antiretroviral Pregnancy Registry A Multi-Site Protocol |
Estimated Enrollment: | 520 |
Study Start Date: | May 2008 |
Estimated Study Completion Date: | January 2010 |
Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
Although the use of HAART in pregnancy has significantly reduced rates of vertical transmission of HIV-1, some questions remain regarding the safety of these therapies and their potential impact on the uninfected infant.
The overall goal of the project is to establish a voluntary exposure-registry and perform observational surveillance on HIV - positive pregnant women who are exposed to antiretroviral products during the prenatal period, in order to evaluate the outcome of the pregnancy and safety of the products in HIV-positive pregnant women, and their infants.
Ages Eligible for Study: | 15 Years to 45 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
HIV positive pregnant women attending ART clinics
Inclusion Criteria:
Exclusion Criteria:
Contact: Lulu Oguda, MD, MPH | 202-296-9165 ext 8485 | loguda@pedaids.org |
Contact: Richard Marlink, MD | 310-491-3144 | ric@pedaids.org |
Côte D'Ivoire | |
Elizabeth Glaser Pediatric AIDS Foundation | |
Abidjan, Côte D'Ivoire | |
Zambia | |
Center for Infectious Disease Research in Zambia (CIDRZ) | |
Lusaka, Zambia |
Principal Investigator: | Richard Marlink, MD | Elizabeth Glaser Pediatric AIDS Foundation |
Study Director: | Lulu Oguda, MD, MPH | Elizabeth Glaser Pediatric AIDS Foundation |
Responsible Party: | Elizabeth Glaser Pediatric AIDS Foundation ( Vice President Technical Implementation ) |
Study ID Numbers: | EGPAF-001 |
Study First Received: | March 14, 2008 |
Last Updated: | April 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00639145 |
Health Authority: | Cote d'Ivoire: National Research and Ethics Committee; United States: Institutional Review Board; Zambia: Research Ethics Committee |
HIV Pregnancy Antiretrovirals HIV Seronegativity Treatment Experienced |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Seropositivity HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
RNA Virus Infections Slow Virus Diseases Immune System Diseases Lentivirus Infections Infection |