CLINICAL TRIALS PROFILE FOR FORTOVASE

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.
NCT00002378 ↗	A Comparison of Three Anti-HIV Drug Combinations Containing Saquinavir Soft Gelatin Capsules Used in HIV-1 Infected Patients	Completed	Hoffmann-La Roche	Phase 3	1969-12-31	To determine the proportion of patients whose plasma HIV-1 RNA level falls below the level of detection (< 400 copies/ml) at week 24 of study therapy. To determine the absolute change in plasma HIV-1 RNA during the 24 weeks of study treatment. To collect safety data on the treatment regimens. AS PER AMENDMENT 12/12/97: To compare the virologic response of Fortovase (FTV) (Saquinavir) Soft Gel Capsule (SGC) tid plus nucleoside reverse transcriptase inhibitors (NRTIs) versus FTV bid plus NRTIs. Further, to compare the virologic response of FTV tid plus NRTIs versus FTV bid plus Nelfinavir bid plus a NRTI with respect to: the percentage of patients whose plasma HIV-1 RNA level falls below the Amplicor assay level of detection (< 400 copies/ml) at week 24 and week 48.
NCT00002397 ↗	A Study of Saquinavir Soft Gel Capsules (SGC) Used in Combination With Two Other Anti-HIV Drugs in Patients With HIV-Associated Kidney Disease	Completed	Hoffmann-La Roche	Phase 3	1969-12-31	The purpose of this study is to compare the safety and effectiveness of saquinavir SGC plus stavudine (d4T) plus lamivudine (3TC) with that of saquinavir SGC plus nelfinavir plus d4T in patients with HIV-associated kidney disease. This study examines whether these drug combinations are effective in preventing kidney disease from progressing to a stage where it is immediately life threatening. This study also examines the effect these drug combinations have on the level of HIV detected in these patients. Finally, this study evaluates the drug level (the amount of drug found in the body) of these two combinations in patients with kidney disease.
NCT00002447 ↗	A Study to Compare Two Anti-HIV Drug Combinations	Completed	Hoffmann-La Roche	Phase 3	1999-10-01	The purpose of this study is to compare 2 anti-HIV drug combinations.

Clinical Trial Conditions for Fortovase

Condition Name

Condition Name for Fortovase
Intervention	Trials
HIV Infections	8
AIDS-Associated Nephropathy	1
Directly Observed Therapy	1
Pregnancy	1

Condition MeSH

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

Clinical Trial Locations for Fortovase

Trials by Country

Trials by Country for Fortovase
Location	Trials
United States	71
Puerto Rico	4
Canada	4
Italy	1
Germany	1

Trials by US State

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

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

Clinical Trial Status

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

Clinical Trial Sponsors for Fortovase

Sponsor Name

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

Sponsor Type

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