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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

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ClinicalTrials.gov Identifier: NCT00000887
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : October 29, 2021
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)

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.

Condition or disease Intervention/treatment Phase
HIV Infections Pregnancy Drug: Nelfinavir mesylate Drug: Lamivudine Drug: Zidovudine Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 24 participants
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
Actual Study Completion Date : July 2004

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000887

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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)
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Study Chair: Yvonne Bryson
Study Chair: Mark Mirochnick
Study Chair: Alice Stek
Publications of Results:
Other Publications:
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)

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Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000887    
Other Study ID Numbers: ACTG 353
10603 ( Registry Identifier: DAIDS ES )
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: October 29, 2021
Last Verified: October 2021
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:
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HIV Infections
Blood-Borne Infections
Communicable Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents
Anti-Retroviral Agents
HIV Protease Inhibitors
Viral Protease Inhibitors
Protease Inhibitors