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| Sponsor: | Elizabeth Glaser Pediatric AIDS Foundation |
|---|---|
| Information provided by: | Elizabeth Glaser Pediatric AIDS Foundation |
| ClinicalTrials.gov Identifier: | NCT00639145 |
Purpose
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 |
|---|
|
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.
Eligibility| 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:
Contacts and Locations| 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 |
More Information
| 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 History of Changes |
| 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 |
|
RNA Virus Infections Sexually Transmitted Diseases, Viral Slow Virus Diseases Immune System Diseases Acquired Immunodeficiency Syndrome Infection Immunologic Deficiency Syndromes |
Virus Diseases HIV Seropositivity HIV Infections Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections |
