A Phase I Study of Safety and Pharmacokinetics of Nevirapine in HIV-1 Infected Pregnant Women and Neonates Born to HIV-1 Infected Mothers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00000808
First received: November 2, 1999
Last updated: March 30, 2012
Last verified: March 2012
  Purpose

To determine the bioavailability, pharmacokinetics, and short-term safety and tolerance of nevirapine in HIV-1 infected pregnant women and their newborns when nevirapine is given to the mother during active labor, and when their neonates are dosed during the first week of life. To determine the short-term safety profile of mothers receiving zidovudine (AZT) who received nevirapine during active labor, and their neonates who received no dose, a single dose, or multiple doses of nevirapine and who are receiving AZT during the first 6 weeks of life.

Treatment of HIV-1 infected pregnant women during active labor may result in therapeutic levels of nevirapine in the neonate at the time of exposure to HIV-1 during parturition, decreasing the neonate's risk of infection.


Condition Intervention Phase
HIV Infections
Pregnancy
Drug: Nevirapine
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Primary Purpose: Treatment
Official Title: A Phase I Study of Safety and Pharmacokinetics of Nevirapine in HIV-1 Infected Pregnant Women and Neonates Born to HIV-1 Infected Mothers

Resource links provided by NLM:


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

Estimated Enrollment: 49
Study Completion Date: September 1998
Detailed Description:

Treatment of HIV-1 infected pregnant women during active labor may result in therapeutic levels of nevirapine in the neonate at the time of exposure to HIV-1 during parturition, decreasing the neonate's risk of infection.

Pregnant women in active labor receive single doses of oral nevirapine. The neonates of the first 4-6 (PER AMENDMENT 8/27/96, was 4) mothers receive no drug, while the neonates of the second 4-6 (PER AMENDMENT 8/27/96, was 4) patient cohort receive a single dose of nevirapine. If neonatal antiviral levels of nevirapine are not sustained for 7 days after the single dose, a third cohort of 4-6 (PER AMENDMENT 8/27/96, was 4) pregnant women will receive a single dose of nevirapine and their neonates will receive multiple doses of nevirapine to maintain an antiviral effect for 7 days.

  Eligibility

Ages Eligible for Study:   13 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

  • AZT (mothers and neonates).
  • Oral asthma inhalers (mothers).

Concurrent Treatment:

Allowed:

  • Phototherapy (neonates).

MOTHERS must have:

  • HIV infection.
  • Estimated gestational age >= 34 weeks.
  • No active opportunistic infection at study entry.

PER AMENDMENT 8/27/96:

  • A pre-enrollment plasma HIV-1 RNA level greater than 10,000 copies/ml.

Exclusion Criteria

Co-existing Condition:

MOTHERS with the following symptoms or conditions are excluded:

  • Intrauterine growth retardation.
  • Fetal anomaly incompatible with life as determined by pre-entry ultrasound.
  • Participation during current pregnancy in any other therapeutic or vaccine perinatal trial.
  • Known hypersensitivity to any benzodiazepine.
  • Serious bacterial infection.

Concurrent Medication:

Excluded:

  • Any antiretroviral other than AZT.
  • Corticosteroids (other than oral asthma inhalers).
  • Anticoagulants.
  • Any clavulanic acid-containing formulation (e.g., Augmentin, Timentin).
  • Benzodiazepines other than study drug.
  • Phenobarbital.
  • Barbiturates.
  • Antacids.
  • Magnesium sulfate.

Prior Medication:

Excluded:

  • Prior nevirapine.

Current use of illicit substances and/or active chronic alcohol use.

  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: NCT00000808

Locations
United States, California
UCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla, California, United States, 920930672
UCLA Med Ctr / Pediatric
Los Angeles, California, United States, 900951752
Harbor - UCLA Med Ctr / UCLA School of Medicine
Los Angeles, California, United States, 905022004
Los Angeles County - USC Med Ctr
Los Angeles, California, United States, 90033
San Francisco Gen Hosp
San Francisco, California, United States, 94110
UCSF / Moffitt Hosp - Pediatric
San Francisco, California, United States, 941430105
United States, Connecticut
Univ of Connecticut / Farmington
Farmington, Connecticut, United States, 06032
Connecticut Children's Med Ctr - Pediatric
Hartford, Connecticut, United States, 06106
United States, Illinois
Chicago Children's Memorial Hosp
Chicago, Illinois, United States, 606143394
Univ of Chicago Children's Hosp
Chicago, Illinois, United States, 606371470
United States, Massachusetts
Children's Hosp of Boston
Boston, Massachusetts, United States, 021155724
Boston City Hosp / Pediatrics
Boston, Massachusetts, United States, 02118
Univ of Massachusetts Med School
Worcester, Massachusetts, United States, 016550001
United States, New Jersey
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark, New Jersey, United States, 071032714
United States, New York
Mount Sinai Med Ctr / Pediatrics
New York, New York, United States, 10029
Puerto Rico
San Juan City Hosp
San Juan, Puerto Rico, 009367344
Sponsors and Collaborators
Investigators
Study Chair: Sullivan JL
Study Chair: Sperling R
  More Information

Additional Information:
Publications:
McKinney RE Jr. Ongoing and future trials of antiretroviral therapy in the pediatric AIDS clinical trials group (PACTG). Conf Retroviruses Opportunistic Infect. 1996 Jan 28-Feb 1;3rd:173
Mirochnick M, Sullivan J, Cort S, Mcnamara J, Fenton T, Sperling R. Safety and pharmacokinetics (pk) of nevirapine (NVP) in HIV-I infected pregnant women and their newborns. ACTG Protocol 250 Team. American Pediatric Association and Society for Pediatric Research annual meeting; 1996 May 6-10; Washington, D.C. Pediatr AIDS HIV Infect. 1996 Aug;7(4):280 (unnumbered abstract)

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000808     History of Changes
Other Study ID Numbers: ACTG 250, 11227
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):
Pregnancy
Pregnancy Complications, Infectious
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Nevirapine

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

ClinicalTrials.gov processed this record on October 01, 2014