Fortovase (Saquinavir) Given with Low-Dose Ritonavir, Zidovudine, and Lamivudine to HIV-Positive Pregnant Women During and After Pregnancy and to Their Newborns - Article Azidothymidine Capsule; AZT Capsule; Compound S Capsule; Retrovir Capsule
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.
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 |
| Drug: Ritonavir |
|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
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.]
Ages Eligible for Study: 13 Years and above, Genders Eligible for Study: Both
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).
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.
Los Angeles County - USC Med Ctr, Los Angeles, California, 90033, United States
Univ of Colorado Health Sciences Ctr, Denver, Colorado, 80262, United States
District of Columbia
Howard Univ Hosp, Washington, District of Columbia, 20060, United States
Univ of Miami (Pediatric), Miami, Florida, 33161, United States
Univ of Miami / Jackson Memorial Hosp, Miami, Florida, 33136, United States
Univ of Illinois College of Medicine / Pediatrics, Chicago, Illinois, 60612, United States
Tulane Univ / Charity Hosp of New Orleans, New Orleans, Louisiana, 701122699, United States
Univ Hosp, New Orleans, Louisiana, 70112, United States
Children's Hosp of Michigan, Detroit, Michigan, 48201, United States
Univ of Medicine & Dentistry of New Jersey / Univ Hosp, Newark, New Jersey, 071032714, United States
Columbia Presbyterian Med Ctr, New York, New York, 10032, United States
Duke Univ Med Ctr, Durham, North Carolina, 277103499, United States
Med Univ of South Carolina, Charleston, South Carolina, 294253312, United States
Children's Hospital & Medical Center / Seattle ACTU, Seattle, Washington, 981050371, United States
Univ of Puerto Rico / Univ Children's Hosp AIDS, San Juan, 009365067, Puerto Rico
Carmen Zorrilla, Study Chair
Arlene Bardeguez, Study Chair
Jane Pitt, Study Chair
Russell Van Dyke, Study Chair
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.
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.
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
Cache Date: April 9, 2005