Clinical Trial: Fortovase (Saquinavir) Given with Low-Dose Ritonavir, Zidovudine, and Lamivudine to HIV-Positive Pregnant Women During and After Pregnancy and to Their Newborns

This study has been completed.

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 it is safe to give saquinavir-SGC (SQV) combined with low-dose ritonavir (RTV) plus zidovudine (ZDV) and lamivudine (3TC) to HIV-positive pregnant women and to see if it is safe to give 3TC and ZDV to their newborns. Another purpose is to see what levels of SQV, low-dose RTV, ZDV, and 3TC are found in mothers and what levels of ZDV and 3TC are seen in newborns. Another purpose of this study is to see whether SQV passes from mother to newborn and if it passes at a level that is safe for the newborn. Although ZDV has been able to reduce the rate of transmission of HIV from mother to child, it may be possible to reduce it further by using a combination of anti-HIV drugs. This study adds SQV (a protease inhibitor [PI]) with RTV (another PI) and 3TC (a reverse transcriptase inhibitor) to the mother's ZDV regimen.

Condition Treatment or Intervention Phase
HIV Infections
Pregnancy
 Drug: Ritonavir
 Drug: Saquinavir
 Drug: Lamivudine
 Drug: Zidovudine
Phase I

MedlinePlus related topics:  AIDS

Study Type: Interventional
Study Design: Treatment, Pharmacokinetics Study

Official Title: A Phase I Trial of the Safety and Pharmacokinetics of Fortovase (Saquinavir-SGC) Co-Administered with Low Dose (Ritonavir) RTV, ZDV and 3TC in HIV Seropositive Pregnant Women During Gestation and Postpartum, and in Their Infant's Post-Maternal Dosing

Further Study Details: 

Expected Total Enrollment:  24

Study start: September 1997

Although administration of ZDV to mother-infant pairs has dramatically reduced perinatal HIV infection, the goal is to reduce it further to less than 2%. In order to achieve this, combination strategies need to be developed for 2 purposes: 1) to reduce the perinatal transmission rate to goal levels; and 2) to provide other combination therapies for HIV-infected mothers whose virus has become resistant to ZDV, who have a very high viral load, or who have previously transmitted HIV while on ZDV. This study adds 3TC (another reverse transcriptase inhibitor) and SQV (a protease inhibitor [PI]) [AS PER AMENDMENT 08/15/00: with low-dose RTV (another PI)] to the mother's ZDV regimen.

During the antepartum period, mothers receive SQV with [AS PER AMENDMENT 08/15/00: low-dose RTV plus] ZDV and 3TC. At onset of active labor, mothers receive loading doses of each of the study drugs, then receive study drugs for 12 weeks postpartum on the same schedule as during the antenatal period. Within 12 hours of delivery, infants begin receiving 3TC and ZDV and continue until 6 weeks of age. Mothers are followed until 12 weeks postpartum and babies are followed until 6 months of age. [AS PER AMENDMENT 02/09/99: For maternal dosing, 1 Combivir tablet (containing 3TC and ZDV) may be administered in place of the individual agents 3TC and ZDV. Patients who prematurely discontinue study treatment should continue to be followed for the duration of the study.]

Eligibility

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

Criteria

Inclusion Criteria

Patients may be eligible for this study if they:

  • Are HIV-positive.
  • Are 14 to 32 weeks pregnant.
  • Are at least 13 years old (need consent of parent or guardian if under 18).

Exclusion Criteria

Patients may not be eligible for this study if they:

  • Cannot take ZDV, 3TC, or higher doses of RTV. Women who are able to tolerate low doses of RTV may be eligible.
  • Are pregnant with more than 1 baby. (This study has been changed so that a patient pregnant with more than 1 baby is not eligible.)
  • Have pregnancy complications or have medical problems that put pregnancy at risk.
  • Have an active opportunistic (HIV-related) infection and/or serious bacterial infection at study entry.
  • Have chronic diarrhea.
  • Abuse alcohol or drugs.
  • Do not have access to a participating clinic or are not willing to be followed at the same clinic for the duration of the study.
  • Have received certain antiretroviral (anti-HIV) drugs or are taking certain medications. (This study has been changed to increase enrollment. The eligibility criterion in earlier versions was more restrictive, and has been changed to include women receiving SQV [with or without RTV], 3TC, and ZDV for longer than 3 weeks if their pre-entry viral load is 400 copies/ml or less OR if they have a significant reduction in viral load within 90 days of the pre-entry visit.)
  • Plan to breast-feed.

Location Information


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

Colorado
      Univ of Colorado Health Sciences Ctr, Denver,  Colorado,  80262,  United States

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

Florida
      Univ of Miami (Pediatric), Miami,  Florida,  33161,  United States

      Univ of Miami / Jackson Memorial Hosp, Miami,  Florida,  33136,  United States

Illinois
      Univ of Illinois College of Medicine / Pediatrics, Chicago,  Illinois,  60612,  United States

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

      Univ Hosp, New Orleans,  Louisiana,  70112,  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

North Carolina
      Duke Univ Med Ctr, Durham,  North Carolina,  277103499,  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
      Univ of Puerto Rico / Univ Children's Hosp AIDS, San Juan,  009365067,  Puerto Rico

Study chairs or principal investigators

Carmen Zorrilla,  Study Chair
Arlene Bardeguez,  Study Chair
Jane Pitt,  Study Chair
Russell Van Dyke,  Study Chair

More Information

Click here for more information about Zidovudine

Click here for more information about Lamivudine

Click here for more information about Saquinavir

Click here for more information about Ritonavir

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

Publications

Acosta EP, Zorrilla C, Van Dyke R, Bardeguez A, Smith E, Hughes M, Huang S, Pitt J, Watts H, Mofenson L. Pharmacokinetics of saquinavir-SGC in HIV-infected pregnant women. HIV Clin Trials. 2001 Nov-Dec;2(6):460-5.

Study ID Numbers:  ACTG 386; PACTG 386
Record last reviewed:  June 2003
Last Updated:  April 7, 2005
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00000920
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


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

Resources