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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00042289 |
The purpose of this study is to determine what doses of anti-HIV medications are appropriate for pregnant women.
Anti-HIV medication taken during pregnancy may control a woman's viral load and reduce the chance that the baby will become infected with HIV. Pregnant women may require different doses of anti-HIV drugs than women who are not pregnant. This study will use pharmacokinetic (PK) sampling to determine what doses of anti-HIV medications are best for HIV infected pregnant women and their infants.
Condition | Intervention |
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HIV Infections |
Procedure: Pharmacokinetic sampling |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Pharmacokinetic Properties of Antiretroviral Drugs During Pregnancy |
Estimated Enrollment: | 275 |
Study Start Date: | March 2003 |
Arms | Assigned Interventions |
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1: Experimental
Participants will be evaluated in order to determine the most effective dosing regimen in preventing perinatal HIV transmission.
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Procedure: Pharmacokinetic sampling
sampling to determine most effective dosing regimen
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Pregnant women experience unique physiological changes that may result in clinically significant alterations in drug PKs. Unfortunately, there have been few clinical trials to study the PK of antiretroviral (ARV) medications in pregnant women. The development of appropriate dosing regimens for the HIV infected pregnant woman is critical to the health of both mother and fetus. Overdosing may lead to maternal adverse events and increased risk of fetal toxicity, while underdosing may lead to inadequate virologic control, increased risk of developing drug resistance mutations, and a higher rate of perinatal HIV transmission. This study will develop and evaluate dosing regimens that are most effective in preventing perinatal HIV transmission and in maintaining the health of both mother and fetus.
Participants will be enrolled in this study starting from their twentieth week of pregnancy and for 12 weeks after delivery. Participants will not receive ARV medications through this study. Medical history, a physical exam, and blood and urine collection will occur during all study visits.
Intensive PK sampling will be performed at study visits during the second and third trimester of pregnancy and between 2 and 3 weeks and 6 and 12 weeks postpartum. The timing of antepartum and postpartum PK samplings will vary by drug. Blood collection from the mother and the detached umbilical cord will occur during delivery. Additional study visits may occur depending on the ARV drug regimen prescribed.
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Shiara Ortiz-Pujols | 301-628-3359 |
Study Chair: | Mark Mirochnick, MD | Boston Medical Center |
Responsible Party: | DAIDS ( Rona Siskind ) |
Study ID Numbers: | PACTG P1026s, PACTG P1025 |
Study First Received: | July 26, 2002 |
Last Updated: | March 4, 2009 |
ClinicalTrials.gov Identifier: | NCT00042289 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Pregnancy Pharmacokinetics Treatment Experienced |
Virus Diseases Sexually Transmitted Diseases, Viral Anti-HIV Agents HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
Virus Diseases Sexually Transmitted Diseases, Viral RNA Virus Infections Slow Virus Diseases Immune System Diseases HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Lentivirus Infections Infection Retroviridae Infections Immunologic Deficiency Syndromes |