A Study to Evaluate the Safety and Tolerance of Nelfinavir (NFV) Given With Zidovudine (ZDV) and Lamivudine (3TC) in HIV-Positive Pregnant Women and Their Infants

NCT00000887 | Completed Phase 1

• 3 other identifiers: ACTG 35310603PACTG 353
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 7

Brief Summary

The purpose of this study is to see if giving nelfinavir (NFV) plus zidovudine (ZDV) plus lamivudine (3TC) to HIV-positive pregnant women and their babies is safe. This study will also look at how long these drugs stay in the blood. ZDV has been given to mothers in the past to reduce the chances of passing HIV on to their babies. However, better treatments are needed to further reduce these chances and to better suit the treatment needs of mothers and their children. Taking a combination of anti-HIV drugs during pregnancy may be an answer.

Conditions

HIV Infections; Pregnancy

Keywords

Pregnancy; Pregnancy Complications, Infectious; Drug Therapy, Combination; Zidovudine; HIV Protease Inhibitors; Lamivudine; Disease Transmission, Vertical; Nelfinavir; Anti-HIV Agents

Interventions

Nelfinavir mesylate DRUG

Lamivudine DRUG

Zidovudine DRUG

Eligibility Criteria

• Age: 13 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients may be eligible for this study if they:
• Are at least 13 years old (need consent of parent or guardian if under 18).
• Are HIV-positive.
• Are in the 2nd or 3rd trimester (14 to 34 weeks pregnant) and are pregnant with one or two children.
• Have a normal ultrasound exam.

You may not qualify if:

• Patients will not be eligible for this study if they:
• Cannot take ZDV or 3TC.
• Have an active opportunistic (HIV-associated) or bacterial infection, or a severe medical condition.
• Have severe diarrhea.
• Are at risk for premature birth or pregnancy complications.
• Have a family history of phenylketonuria (PKU).
• Plan to breast-feed.
• Abuse alcohol or drugs.
• Cannot visit the same clinic for the duration of the study.
• Have taken certain anti-HIV drugs.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (7)

Usc La Nichd Crs

Los Angeles, California, 90033, United States

Location

Tulane Univ. Health Science Ctr., Tulane Univ. Hosp. & Clinic

New Orleans, Louisiana, 701122699, United States

Location

Tulane/LSU Maternal/Child CRS

New Orleans, Louisiana, 70112, United States

Location

Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases

Baltimore, Maryland, 212874933, United States

Location

HMS - Children's Hosp. Boston, Div. of Infectious Diseases

Boston, Massachusetts, 021155724, United States

Location

UNC at Chapel Hill School of Medicine - Dept. of Peds., Div. of Immunology & Infectious Diseases

Chapel Hill, North Carolina, 27710, United States

Location

St. Christopher's Hosp. for Children

Philadelphia, Pennsylvania, 191341095, United States

Location

Related Publications (2)

• Bryson Y, Stek A, Mirochnick M, et al. Pharmacokinetics, antiviral activity, and safety of nelfinavir (NFV) with ZDV/3TC in pregnant HIV-infected women and their infants. PACTG 353 cohort 2. 9th Conference on Retroviruses and Opportunistic Infections. 2002, February 24-28; Seattle Washington (abstract no 795)

  BACKGROUND

• Bryson YJ, Mirochnick M, Stek A, Mofenson LM, Connor J, Capparelli E, Watts DH, Huang S, Hughes MD, Kaiser K, Purdue L, Asfaw Y, Keller M, Smith E; PACTG 353 Team. Pharmacokinetics and safety of nelfinavir when used in combination with zidovudine and lamivudine in HIV-infected pregnant women: Pediatric AIDS Clinical Trials Group (PACTG) Protocol 353. HIV Clin Trials. 2008 Mar-Apr;9(2):115-25. doi: 10.1310/hct0902-115.

  PMID: 18474496 RESULT

MeSH Terms

Conditions

HIV Infections; Pregnancy Complications, Infectious

Interventions

Nelfinavir; Lamivudine; Zidovudine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications

Intervention Hierarchy (Ancestors)

Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Zalcitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Dideoxynucleosides; Thymidine

Study Officials

• Yvonne Bryson

  STUDY CHAIR

• Mark Mirochnick

  STUDY CHAIR

• Alice Stek

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Study Completion: July 1, 2004
• Last Updated: October 29, 2021

Record last verified: 2021-10

Locations

US (7)