Clinical Trial: 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 is no longer recruiting patients.

Sponsors and Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Child Health and Human Development (NICHD)
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)

Purpose

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 Treatment or Intervention Phase
HIV Infections
Pregnancy
 Drug: Nelfinavir mesylate
 Drug: Lamivudine
 Drug: Zidovudine
Phase I

MedlinePlus related topics:  AIDS

Study Type: Interventional
Study Design: Treatment, Safety Study

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: 

Expected Total Enrollment:  24

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.

Eligibility

Ages Eligible for Study:  13 Years and above,  Genders Eligible for Study:  Female

Criteria

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.

Location Information


California
      UCSD Med Ctr / Pediatrics / Clinical Sciences, La Jolla,  California,  920930672,  United States

      Harbor - UCLA Med Ctr / UCLA School of Medicine, Los Angeles,  California,  905022004,  United States

      UCLA Med Ctr / Pediatric, Los Angeles,  California,  900951752,  United States

      Los Angeles County - USC Med Ctr, Los Angeles,  California,  90033,  United States

District of Columbia
      Howard Univ Hosp, Washington,  District of Columbia,  20060,  United States

Florida
      Univ of Florida Health Science Ctr / Pediatrics, Jacksonville,  Florida,  32209,  United States

Illinois
      Cook County Hosp, Chicago,  Illinois,  60612,  United States

      Univ of Chicago Children's Hosp, Chicago,  Illinois,  606371470,  United States

      Mt Sinai Hosp Med Ctr / Dept of Pediatrics, Chicago,  Illinois,  60608,  United States

Louisiana
      Tulane Univ / Charity Hosp of New Orleans, New Orleans,  Louisiana,  701122699,  United States

      Univ Hosp, New Orleans,  Louisiana,  70112,  United States

Maryland
      Univ of Maryland at Baltimore / Univ Med Ctr, Baltimore,  Maryland,  21201,  United States

      Johns Hopkins Hosp - Pediatric, Baltimore,  Maryland,  212874933,  United States

Massachusetts
      Children's Hosp of Boston, Boston,  Massachusetts,  021155724,  United States

      Boston City Hosp / Pediatrics, Boston,  Massachusetts,  02118,  United States

      Baystate Med Ctr of Springfield, Springfield,  Massachusetts,  01199,  United States

      Univ of Massachusetts Med School, Worcester,  Massachusetts,  016550001,  United States

Michigan
      Children's Hosp of Michigan, Detroit,  Michigan,  48201,  United States

New Jersey
      Univ of Medicine & Dentistry of New Jersey / Univ Hosp, Newark,  New Jersey,  071032714,  United States

New York
      Columbia Presbyterian Med Ctr, New York,  New York,  10032,  United States

      Bronx Lebanon Hosp Ctr, Bronx,  New York,  10457,  United States

North Carolina
      Univ of North Carolina at Chapel Hill / Duke Univ Med Ctr, Durham,  North Carolina,  27710,  United States

Pennsylvania
      Temple Univ School of Medicine, Philadelphia,  Pennsylvania,  191341095,  United States

      Saint Christopher's Hosp for Children, Philadelphia,  Pennsylvania,  191341095,  United States

South Carolina
      Med Univ of South Carolina, Charleston,  South Carolina,  294253312,  United States

Washington
      Children's Hospital & Medical Center / Seattle ACTU, Seattle,  Washington,  981050371,  United States

Puerto Rico
      San Juan City Hosp, San Juan,  009367344,  Puerto Rico

Study chairs or principal investigators

Yvonne Bryson,  Study Chair
Mark Mirochnick,  Study Chair
Alice Stek,  Study Chair

More Information

Click here for more information about Zidovudine

Click here for more information about Lamivudine

Click here for more information about Nelfinavir mesylate

Haga clic aquí para ver información sobre este ensayo clínico en español.

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)

Study ID Numbers:  ACTG 353; PACTG 353
Record last reviewed:  September 2004
Last Updated:  April 7, 2005
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00000887
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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