Fortovase (Saquinavir) Given With Low-Dose Ritonavir, Zidovudine, and Lamivudine to HIV-Positive Pregnant Women During and After Pregnancy and to Their Newborns
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
3 other identifiers
interventional
24
2 countries
15
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 hiv-infections
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2003
CompletedOctober 29, 2021
October 1, 2021
November 2, 1999
October 27, 2021
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033, United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262, United States
Howard Univ Hosp
Washington D.C., District of Columbia, 20060, United States
Univ of Miami / Jackson Memorial Hosp
Miami, Florida, 33136, United States
Univ of Miami (Pediatric)
Miami, Florida, 33161, 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
Related Publications (1)
Acosta EP, Zorrilla C, Van Dyke R, Bardeguez A, Smith E, Hughes M, Huang S, Pitt J, Watts H, Mofenson L; Pediatric AIDS Clinical Trials Group 386 Protocol Team. Pharmacokinetics of saquinavir-SGC in HIV-infected pregnant women. HIV Clin Trials. 2001 Nov-Dec;2(6):460-5. doi: 10.1310/PUY3-5JWL-FX2B-98VU.
PMID: 11742433BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Carmen Zorrilla
- STUDY CHAIR
Arlene Bardeguez
- STUDY CHAIR
Jane Pitt
- STUDY CHAIR
Russell Van Dyke