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Last Updated: May 11, 2021

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CLINICAL TRIALS PROFILE FOR FORTOVASE

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All Clinical Trials for Fortovase

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000920 Fortovase (Saquinavir) Given With Low-Dose Ritonavir, Zidovudine, and Lamivudine to HIV-Positive Pregnant Women During and After Pregnancy and to Their Newborns Completed Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Phase 1 1969-12-31 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.
NCT00000920 Fortovase (Saquinavir) Given With Low-Dose Ritonavir, Zidovudine, and Lamivudine to HIV-Positive Pregnant Women During and After Pregnancy and to Their Newborns Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 1 1969-12-31 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.
NCT00002229 Safety and Effectiveness of Adding Saquinavir (FORTOVASE) in Soft Gel Capsule Form to an Anti-HIV Drug Combination in HIV-Infected Patients Completed Hoffmann-La Roche Phase 4 1969-12-31 The purpose of this study is to see if it is safe and effective to give saquinavir (as a soft gel capsule taken by mouth) along with 2 other anti-HIV drugs to HIV-infected patients.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Fortovase

Condition Name

Condition Name for Fortovase
Intervention Trials
HIV Infections 8
Pregnancy 1
Directly Observed Therapy 1
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Condition MeSH

Condition MeSH for Fortovase
Intervention Trials
HIV Infections 8
AIDS-Associated Nephropathy 1
Kidney Diseases 1
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Clinical Trial Locations for Fortovase

Trials by Country

Trials by Country for Fortovase
Location Trials
United States 71
Puerto Rico 4
Canada 4
Germany 1
United Kingdom 1
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Trials by US State

Trials by US State for Fortovase
Location Trials
New Jersey 6
California 5
New York 5
Illinois 4
Florida 4
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Clinical Trial Progress for Fortovase

Clinical Trial Phase

Clinical Trial Phase for Fortovase
Clinical Trial Phase Trials
Phase 4 1
Phase 3 5
Phase 1 2
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Clinical Trial Status

Clinical Trial Status for Fortovase
Clinical Trial Phase Trials
Completed 7
Terminated 1
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Clinical Trial Sponsors for Fortovase

Sponsor Name

Sponsor Name for Fortovase
Sponsor Trials
Hoffmann-La Roche 6
National Institute of Allergy and Infectious Diseases (NIAID) 1
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) 1
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Sponsor Type

Sponsor Type for Fortovase
Sponsor Trials
Industry 7
NIH 2
Other 1
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