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

Sponsored by:	National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00000808

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 I

Study Type:	Interventional
Study Design:	Treatment, Pharmacokinetics Study
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:

MedlinePlus related topics: AIDS AIDS and Pregnancy

Drug Information available for: Nevirapine

U.S. FDA Resources

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

Estimated Enrollment:

49

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000808

Locations

United States, California
UCSF / Moffitt Hosp - Pediatric
San Francisco, California, United States, 941430105
UCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla, California, United States, 920930672
San Francisco Gen Hosp
San Francisco, California, United States, 94110
Harbor - UCLA Med Ctr / UCLA School of Medicine
Los Angeles, California, United States, 905022004
UCLA Med Ctr / Pediatric
Los Angeles, California, United States, 900951752
Los Angeles County - USC Med Ctr
Los Angeles, California, United States, 90033
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

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

Study Chair:	Sullivan JL
Study Chair:	Sperling R

More Information

Additional Information:

Click here for more information about Nevirapine This link exits the ClinicalTrials.gov site

Publications:

Vazquez E. Two bucks a baby. Posit Aware. 1997 Mar-Apr;8(2):15. No abstract available.

Benson M, Shannon M. Nevirapine: ethical dilemmas and care for HIV-infected mothers. Focus. 1995 Jun;10(7):5-6. No abstract available.

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)

Mirochnick M, Fenton T, Gagnier P, Pav J, Gwynne M, Siminski S, Sperling RS, Beckerman K, Jimenez E, Yogev R, Spector SA, Sullivan JL. Pharmacokinetics of nevirapine in human immunodeficiency virus type 1-infected pregnant women and their neonates. Pediatric AIDS Clinical Trials Group Protocol 250 Team. J Infect Dis. 1998 Aug;178(2):368-74.

Study ID Numbers:	ACTG 250
Study First Received:	November 2, 1999
Last Updated:	July 11, 2008
ClinicalTrials.gov Identifier:	NCT00000808 History of Changes
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

Study placed in the following topic categories:

Sexually Transmitted Diseases, Viral
Pregnancy Complications
Anti-HIV Agents
Pregnancy Complications, Infectious
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Antiviral Agents
Immunologic Deficiency Syndromes

Reverse Transcriptase Inhibitors
Virus Diseases
Nevirapine
Anti-Retroviral Agents
HIV Infections
Sexually Transmitted Diseases
Retroviridae Infections

Additional relevant MeSH terms:

Anti-Infective Agents
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Anti-HIV Agents
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Infection
Antiviral Agents
Pharmacologic Actions

Immunologic Deficiency Syndromes
Reverse Transcriptase Inhibitors
Virus Diseases
Nevirapine
Anti-Retroviral Agents
HIV Infections
Therapeutic Uses
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on July 02, 2009