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A Study of Nevirapine to Prevent HIV Transmission From Mothers to Their Babies

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00000942
First received: November 2, 1999
Last updated: March 30, 2012
Last verified: March 2012
  Purpose

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
HIV Infections
Pregnancy
Drug: Nevirapine
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: A Phase III Randomized, Double-Blinded Study of Nevirapine for the Prevention of Maternal-Fetal Transmission in Pregnant HIV-Infected Women

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 1244
Study Completion Date: May 2001
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

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000942

Locations
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
Sponsors and Collaborators
Investigators
Study Chair: Alejandro Dorenbaum, MD
Study Chair: John L. Sullivan, MD
  More Information

Additional Information:
Publications:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000942     History of Changes
Other Study ID Numbers: ACTG 316A, 11291
Study First Received: November 2, 1999
Last Updated: March 30, 2012
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Placebos
Pregnancy
Pregnancy Complications, Infectious
Nevirapine
Disease Transmission, Vertical
Labor
Anti-HIV Agents

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Anti-HIV Agents
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Nevirapine
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014