Clinical Trials


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

This study has been completed
National Institute of Allergy and Infectious Diseases (NIAID)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Information provided by (Responsible Party)
National Institute of Allergy and Infectious Diseases (NIAID) Identifier

First received: November 2, 1999
Last updated: May 21, 2012
Last Verified: May 2012
History of Changes


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.

Condition Intervention Phase
HIV Infections

Drug : Nelfinavir mesylate
Drug : Lamivudine
Drug : Zidovudine
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase I Trial of the Safety, Tolerance, and Pharmacokinetics of Oral Nelfinavir (Viracept) Co-Administered With Zidovudine (ZDV) and Lamivudine (3TC) in HIV Infected Pregnant Women and Their Infants

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

Enrollment: 24
Study Completion Date: July 2004

Detailed Description:

Despite the dramatic reduction of perinatal HIV transmission by the administration of ZDV to mother and infant, new and more potent strategies are needed to further reduce perinatal transmission and better suit the diverse treatment needs of these patients. Initiation of triple antiretroviral combinations during gestation, particularly combinations that include drugs that cross the placenta such as 3TC, may be the most effective in reducing maternal virus load to its lowest levels prior to delivery.
Women receive nelfinavir plus 3TC plus ZDV antepartum (Study Day 0 until onset of active labor) through postpartum (after cord clamped to 12 weeks). [AS PER AMENDMENT 10/28/97: If patient presents in active labor with less than 1 hour to delivery time, the institutional protocol for ZDV infusion during labor should be followed.] [AS PER AMENDMENT 1/26/99: For maternal dosing, one Combivir tablet bid can be substituted for the individual formulation of 3TC and ZDV. For mothers who receive Combivir during the antepartum period, Combivir is held during labor and delivery, and the separate formulations of ZDV and 3TC are used. Patients who prematurely discontinue study treatment should continue to be followed on study for the duration of the study.] Full pharmacokinetic sampling is performed 10 to 15 days after start of therapy [AS PER AMENDMENT 2/7/00: 10 to 15 days after study entry for women currently taking nelfinavir] and again 5 to 6 weeks after delivery. A maternal blood sample and cord blood sample is collected at birth for analysis of nelfinavir concentrations. Maternal HIV RNA in plasma is monitored throughout the study. Cervicovaginal secretions are collected at entry, late gestation, and postpartum to assess the presence of HIV. A single pharmacokinetics sample is collected with each cervicovaginal secretion. Serial CD4/CD8 activation markers are measured in women during gestation and postpartum. Infants receive nelfinavir plus 3TC plus ZDV beginning approximately 12 hours following birth and continuing for 6 weeks. After birth, several blood samples are collected from the infant for determination of washout kinetics of nelfinavir. Full pharmacokinetics sampling is performed 5 to 8 days post birth and 5 to 6 weeks following multiple doses. Pharmacokinetic samples are analyzed on the first six mother-infant pairs and dosing may be adjusted accordingly for the next cohort. Agouron has agreed to make nelfinavir available to all interested study participants for a period of 6 months after the study via the patient assistance program.



Ages Eligible for Study: 13 Years and older  
Sexes Eligible for Study: Female  
Accepts Healthy Volunteers: No  


Inclusion Criteria
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.

  • Exclusion Criteria
    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.

contacts and locations

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 identifier: NCT00000887


United States, California
Usc La Nichd Crs
Los Angeles, California, United States, 90033
United States, Louisiana
Tulane Univ. Health Science Ctr., Tulane Univ. Hosp. & Clinic
New Orleans, Louisiana, United States, 701122699
Tulane/LSU Maternal/Child CRS
New Orleans, Louisiana, United States, 70112
United States, Maryland
Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases
Baltimore, Maryland, United States, 212874933
United States, Massachusetts
HMS - Children's Hosp. Boston, Div. of Infectious Diseases
Boston, Massachusetts, United States, 021155724
United States, North Carolina
UNC at Chapel Hill School of Medicine - Dept. of Peds., Div. of Immunology & Infectious Diseases
Chapel Hill, North Carolina, United States, 27710
United States, Pennsylvania
St. Christopher's Hosp. for Children
Philadelphia, Pennsylvania, United States, 191341095

Sponsors and Collaborators

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


Study Chair: Yvonne Bryson
Study Chair: Mark Mirochnick
Study Chair: Alice Stek
More Information

More Information

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID) Identifier: NCT00000887   History of Changes  
Other Study ID Numbers: ACTG 353  
  PACTG 353  
Study First Received: November 2, 1999  
Last Updated: May 21, 2012  

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):

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

Additional relevant MeSH terms:
HIV Infections
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