Fortovase (Saquinavir) Given With Low-Dose Ritonavir, Zidovudine, and Lamivudine to HIV-Positive Pregnant Women During and After Pregnancy and to Their Newborns
Public ClinicalTrials.gov record NCT00000920. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00000920
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 24 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 13 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Not listed
- Primary completion
- Not listed
- Completion
- Mar 31, 2003
- Last update posted
- Oct 28, 2021
Ends 2003
United States locations
- U.S. sites
- 14
- U.S. states
- 12
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Los Angeles County - USC Med Ctr | Los Angeles | California | 90033 | — |
| Univ of Colorado Health Sciences Ctr | Denver | Colorado | 80262 | — |
| Howard Univ Hosp | Washington D.C. | District of Columbia | 20060 | — |
| Univ of Miami / Jackson Memorial Hosp | Miami | Florida | 33136 | — |
| Univ of Miami (Pediatric) | Miami | Florida | 33161 | — |
| Univ of Illinois College of Medicine / Pediatrics | Chicago | Illinois | 60612 | — |
| Tulane Univ / Charity Hosp of New Orleans | New Orleans | Louisiana | 701122699 | — |
| Univ Hosp | New Orleans | Louisiana | 70112 | — |
| Children's Hosp of Michigan | Detroit | Michigan | 48201 | — |
| Univ of Medicine & Dentistry of New Jersey / Univ Hosp | Newark | New Jersey | 071032714 | — |
| Columbia Presbyterian Med Ctr | New York | New York | 10032 | — |
| Duke Univ Med Ctr | Durham | North Carolina | 277103499 | — |
| Med Univ of South Carolina | Charleston | South Carolina | 294253312 | — |
| Children's Hospital & Medical Center / Seattle ACTU | Seattle | Washington | 981050371 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00000920, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 28, 2021 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00000920 live on ClinicalTrials.gov.