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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000808
• Other study ID #: ACTG 250
• Secondary ID: 11227
• Status: Completed
• Phase: Phase 1
• Est. completion date: September 1998

Study information

• Verified date: October 2021
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: September 1998
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 13 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• HIV Infections
• Pregnancy

Intervention

Drug:
• Nevirapine

Locations

Country	Name	City	State
Puerto Rico	San Juan City Hosp	San Juan
United States	Boston City Hosp / Pediatrics	Boston	Massachusetts
United States	Children's Hosp of Boston	Boston	Massachusetts
United States	Chicago Children's Memorial Hosp	Chicago	Illinois
United States	Univ of Chicago Children's Hosp	Chicago	Illinois
United States	Univ of Connecticut / Farmington	Farmington	Connecticut
United States	Connecticut Children's Med Ctr - Pediatric	Hartford	Connecticut
United States	UCSD Med Ctr / Pediatrics / Clinical Sciences	La Jolla	California
United States	Harbor - UCLA Med Ctr / UCLA School of Medicine	Los Angeles	California
United States	Los Angeles County - USC Med Ctr	Los Angeles	California
United States	UCLA Med Ctr / Pediatric	Los Angeles	California
United States	Mount Sinai Med Ctr / Pediatrics	New York	New York
United States	Univ of Medicine & Dentistry of New Jersey / Univ Hosp	Newark	New Jersey
United States	San Francisco Gen Hosp	San Francisco	California
United States	UCSF / Moffitt Hosp - Pediatric	San Francisco	California
United States	Univ of Massachusetts Med School	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Countries where clinical trial is conducted

United States,  Puerto Rico, 

References & Publications (5)

Benson M, Shannon M. Nevirapine: ethical dilemmas and care for HIV-infected mothers. Focus. 1995 Jun;10(7):5-6. — View 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

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. — View 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)

Vazquez E. Two bucks a baby. Posit Aware. 1997 Mar-Apr;8(2):15. — View Citation