A Study of Nevirapine to Prevent HIV Transmission From Mothers to Their Babies
Information source: National Institute of Allergy and Infectious Diseases (NIAID)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections; Pregnancy
Intervention: Nevirapine (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID) Official(s) and/or principal investigator(s):
Alejandro Dorenbaum, MD, Study Chair
John L. Sullivan, MD, Study Chair
Summary
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.
Clinical Details
Official title: A Phase III Randomized, Double-Blinded Study of Nevirapine for the Prevention of Maternal-Fetal Transmission in Pregnant HIV-Infected Women
Study design: Prevention, Double-Blind, Efficacy Study
Detailed description:
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.
Eligibility
Minimum age: 13 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria
You may be eligible for this study if you:
- Are an HIV-positive pregnant woman.
- Have been pregnant for at least 28 weeks.
- Are at least 13 years of age (consent of parent or guardian is required if under 18).
Exclusion Criteria
You will not be eligible for this study if:
- Your baby will not live.
- You intend to breast-feed.
- You are allergic to benzodiazepines (a tranquilizer).
- You have a liver disorder.
- You have received non-nucleoside reverse transcriptase inhibitors (a class of anti-HIV
drugs).
Locations and Contacts
Princess Margaret Hosp, Nassau, Bahamas
Hopital Hotel Dieu de Lyon, Lyon, France
CHRU de Nantes, Nantes, France
Universita Frederico II, Napoli, Italy
Hosp Doce De Octubre, Madrid, Spain
Additional Information
Click here for more information about nevirapine Haga clic aquí para ver información sobre este ensayo clínico en español.
Related publications: Cunningham CK, Balasubramanian R, Delke I, Maupin R, Mofenson L, Dorenbaum A, Sullivan JL, Gonzalez-Garcia A, Thorpe E, Rathore M, Gelber RD. The Impact of Race/Ethnicity on Mother-to-Child HIV Transmission in the United States in Pediatric AIDS Clinical Trials Group Protocol 316. J Acquir Immune Defic Syndr. 2004 Jul 1;36(3):800-807. Watts DH, Balasubramanian R, Maupin RT Jr, Delke I, Dorenbaum A, Fiore S, Newell ML, Delfraissy JF, Gelber RD, Mofenson LM, Culnane M, Cunningham CK; PACTG 316 Study Team. Maternal toxicity and pregnancy complications in human immunodeficiency virus-infected women receiving antiretroviral therapy: PACTG 316. Am J Obstet Gynecol. 2004 Feb;190(2):506-16.
Last updated: June 23, 2005
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