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

Primary Purpose

HIV Infections, Pregnancy

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Nevirapine
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Pregnancy, Pregnancy Complications, Infectious, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Nevirapine

Eligibility Criteria

13 Years - 60 Years (Child, Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • UCSD Med Ctr / Pediatrics / Clinical Sciences
  • Los Angeles County - USC Med Ctr
  • UCLA Med Ctr / Pediatric
  • Harbor - UCLA Med Ctr / UCLA School of Medicine
  • San Francisco Gen Hosp
  • UCSF / Moffitt Hosp - Pediatric
  • Univ of Connecticut / Farmington
  • Connecticut Children's Med Ctr - Pediatric
  • Chicago Children's Memorial Hosp
  • Univ of Chicago Children's Hosp
  • Children's Hosp of Boston
  • Boston City Hosp / Pediatrics
  • Univ of Massachusetts Med School
  • Univ of Medicine & Dentistry of New Jersey / Univ Hosp
  • Mount Sinai Med Ctr / Pediatrics
  • San Juan City Hosp

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
October 27, 2021
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00000808
Brief 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
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 1998 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Pregnancy
Keywords
Pregnancy, Pregnancy Complications, Infectious, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Nevirapine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Enrollment
49 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Nevirapine

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sullivan JL
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sperling R
Official's Role
Study Chair
Facility Information:
Facility Name
UCSD Med Ctr / Pediatrics / Clinical Sciences
City
La Jolla
State/Province
California
ZIP/Postal Code
920930672
Country
United States
Facility Name
Los Angeles County - USC Med Ctr
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
UCLA Med Ctr / Pediatric
City
Los Angeles
State/Province
California
ZIP/Postal Code
900951752
Country
United States
Facility Name
Harbor - UCLA Med Ctr / UCLA School of Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
905022004
Country
United States
Facility Name
San Francisco Gen Hosp
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Facility Name
UCSF / Moffitt Hosp - Pediatric
City
San Francisco
State/Province
California
ZIP/Postal Code
941430105
Country
United States
Facility Name
Univ of Connecticut / Farmington
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06032
Country
United States
Facility Name
Connecticut Children's Med Ctr - Pediatric
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
Facility Name
Chicago Children's Memorial Hosp
City
Chicago
State/Province
Illinois
ZIP/Postal Code
606143394
Country
United States
Facility Name
Univ of Chicago Children's Hosp
City
Chicago
State/Province
Illinois
ZIP/Postal Code
606371470
Country
United States
Facility Name
Children's Hosp of Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
021155724
Country
United States
Facility Name
Boston City Hosp / Pediatrics
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Univ of Massachusetts Med School
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
016550001
Country
United States
Facility Name
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
City
Newark
State/Province
New Jersey
ZIP/Postal Code
071032714
Country
United States
Facility Name
Mount Sinai Med Ctr / Pediatrics
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
San Juan City Hosp
City
San Juan
ZIP/Postal Code
009367344
Country
Puerto Rico

12. IPD Sharing Statement

Citations:
PubMed Identifier
11364450
Citation
Vazquez E. Two bucks a baby. Posit Aware. 1997 Mar-Apr;8(2):15.
Results Reference
background
PubMed Identifier
11362587
Citation
Benson M, Shannon M. Nevirapine: ethical dilemmas and care for HIV-infected mothers. Focus. 1995 Jun;10(7):5-6.
Results Reference
background
Citation
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
Results Reference
background
Citation
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)
Results Reference
background
PubMed Identifier
9697716
Citation
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. doi: 10.1086/515641.
Results Reference
background

Learn more about this trial

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

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