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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000942 |
The purpose of this study is to see if giving the anti-HIV drug nevirapine (NVP) to HIV-positive pregnant women and their babies can help reduce the chance that a mother will give HIV to her baby during delivery.
Previous studies suggest that NVP is a promising medication for blocking HIV transmission from HIV-positive mothers to their babies.
Condition | Intervention | Phase |
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HIV Infections Pregnancy |
Drug: Nevirapine |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Double-Blind, Efficacy Study |
Official Title: | A Phase III Randomized, Double-Blinded Study of Nevirapine for the Prevention of Maternal-Fetal Transmission in Pregnant HIV-Infected Women |
Estimated Enrollment: | 1244 |
NVP has several properties that make it an attractive candidate for antiretroviral therapy to interrupt HIV-1 transmission in the intrapartum and early post-partum period. The pharmacokinetic profile suggests that NVP would be rapidly absorbed and transferred to the infant in utero when given during labor and delivery. The HIV-1 antiviral activity is rapid with significant reduction in plasma virus occurring within a few days of drug administration. In addition, NVP has been shown to penetrate cell-free virions and inactivate virion-associated RT in situ. This property would be potentially useful in inactivating cell-free virions in the genital tract as well as in breast milk. These characteristics of NVP suggest that treatment of an HIV-infected pregnant woman in labor with an oral dose of NVP may provide a prophylactic level of NVP in the infant during the time of exposure to virus in the birth canal and/or maternal blood. In addition, NVP may inactivate the virion-associated RT present in cell-free virions in the genital tract or breast milk.
Mothers are randomized to receive either a single oral dose of NVP during labor or the corresponding NVP placebo. Randomization occurs at any time after the 28th week of gestation. To assure balance between the treatment groups, the randomization is stratified using 2 factors: 1) use of antiretroviral therapy during the current pregnancy (no antiretroviral therapy at all; monotherapy [with no multi-agent therapy] for any duration; multi-agent therapy for any duration), and 2) CD4 cell count at the time of randomization (less than 200 cells; 200 to 399 cells; 400 cells or greater). Mothers are followed on-study for 4 to 6 weeks postpartum.
Due to the results of ACTG 076 and 185, all women for entry into ACTG 316 are encouraged to incorporate a regimen of zidovudine (ZDV) into their current treatment regimen and should continue ZDV during delivery and to their neonates (for at least 6 weeks post-birth).
Infants receive a single oral dose of NVP (or the corresponding placebo) administered between 48 and 72 hours of life. The infant's study drug is the same as the mother's randomized treatment assignment. Infants are dosed with study drug according to their randomization group regardless of whether the mother received study drug or not. Infants are followed for 6 months of life, and are tested for HIV at birth, 4 to 6 weeks of life, 3 months of life, and 6 months of life.
Ages Eligible for Study: | 13 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
You may be eligible for this study if you:
Exclusion Criteria
You will not be eligible for this study if:
Bahamas | |
Princess Margaret Hosp | |
Nassau, Bahamas | |
France | |
Hopital Hotel Dieu de Lyon | |
Lyon, France | |
CHRU de Nantes | |
Nantes, France | |
Italy | |
Universita Frederico II | |
Napoli, Italy | |
Spain | |
Hosp Doce De Octubre | |
Madrid, Spain |
Study Chair: | Alejandro Dorenbaum, MD | |
Study Chair: | John L. Sullivan, MD |
Study ID Numbers: | ACTG 316A |
Study First Received: | November 2, 1999 |
Last Updated: | July 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00000942 |
Health Authority: | United States: Federal Government |
Placebos Pregnancy Pregnancy Complications, Infectious Nevirapine |
Disease Transmission, Vertical Labor Anti-HIV Agents |
Virus Diseases Nevirapine Sexually Transmitted Diseases, Viral Pregnancy Complications HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Pregnancy Complications, Infectious Retroviridae Infections Immunologic Deficiency Syndromes |
Anti-Infective Agents RNA Virus Infections Slow Virus Diseases Anti-HIV Agents Molecular Mechanisms of Pharmacological Action Immune System Diseases Enzyme Inhibitors Infection |
Antiviral Agents Pharmacologic Actions Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Lentivirus Infections Nucleic Acid Synthesis Inhibitors |