Pharmacokinetics of saquinavir-SGC in HIV-infected pregnant women.
E P Acosta, C Zorrilla, R Van Dyke...
https://pubmed.ncbi.nlm.nih.gov/11742433Completed
Phase 1
Age: 13Years +
All Genders
ID00000920
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
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2021-10-29
24
Participants Needed
15
Research Sites
N/A
Total Duration
On this page
Sponsors
N
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor
E
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Fortovase (Saquinavir) Given With Low-Dose Ritonavir, Zidovudine, and Lamivudine to HIV-Positive Pregnant Women During and After Pregnancy and to Their Newborns
Who Can Participate
Age: 13Years +
All Genders
Eligibility Criteria
You may qualify if you...
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.
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
Trial Site Locations
Total: 15 locations
1
Los Angeles County - USC Med Ctr
Los Angeles, California, United States, 90033
Status Unknown
2
Univ of Colorado Health Sciences Ctr
Denver, Colorado, United States, 80262
Status Unknown
3
Howard Univ Hosp
Washington D.C., District of Columbia, United States, 20060
Status Unknown
4
Univ of Miami / Jackson Memorial Hosp
Miami, Florida, United States, 33136
Status Unknown
5
Univ of Miami (Pediatric)
Miami, Florida, United States, 33161
Status Unknown
6
Univ of Illinois College of Medicine / Pediatrics
Chicago, Illinois, United States, 60612
Status Unknown
7
Tulane Univ / Charity Hosp of New Orleans
New Orleans, Louisiana, United States, 701122699
Status Unknown
8
Univ Hosp
New Orleans, Louisiana, United States, 70112
Status Unknown
9
Children's Hosp of Michigan
Detroit, Michigan, United States, 48201
Status Unknown
10
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark, New Jersey, United States, 071032714
Status Unknown
11
Columbia Presbyterian Med Ctr
New York, New York, United States, 10032
Status Unknown
12
Duke Univ Med Ctr
Durham, North Carolina, United States, 277103499
Status Unknown
13
Med Univ of South Carolina
Charleston, South Carolina, United States, 294253312
Status Unknown
14
Children's Hospital & Medical Center / Seattle ACTU
Seattle, Washington, United States, 981050371
Status Unknown
15
Univ of Puerto Rico / Univ Children's Hosp AIDS
San Juan, Puerto Rico, 009365067
Status Unknown
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
TREATMENT
Number of Arms
0
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