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Generated: December 18, 2018

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CLINICAL TRIALS PROFILE FOR SAQUINAVIR

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Clinical Trials for Saquinavir

Trial ID Title Status Sponsor Phase Summary
NCT00000848 The Anti-HIV Effects of Saquinavir Soft Gelatin Capsules Versus Indinavir in Patients Who Have Used Saquinavir Hard Gelatin Capsules for One Year Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 2 To determine, in HIV-infected patients, whether switching to a new soft gelatin capsule formulation of saquinavir or to indinavir following prolonged use of the original hard capsule formulation of saquinavir results in an acute decrease in plasma HIV RNA. Resistance to anti-HIV agents occurs with increasing duration of use. In vitro studies have shown that cross-resistance occurs among protease inhibitors, although no clinical trials have been conducted to examine antiretroviral activity with sequential use of protease inhibitors or to determine whether saquinavir resistance can be overcome with higher concentrations of the drug.
NCT00000891 Immunologic and Virologic Consequences of Long-Term Highly Active Antiretroviral Therapy (HAART) in Subjects With Moderately Advanced HIV-1 Disease: A Follow-Up Study to ACTG 315 Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 2 To evaluate the relationship between viral suppression and changes in immune function, as measured by the restoration of delayed-type hypersensitivity (DTH) and lymphoproliferative (LP) responses, observed after 48 weeks of treatment with highly active antiretroviral therapy (HAART) in ACTG 315. To evaluate the durability of the antiviral and immunologic effects of long-term treatment with HAART. Given the extensive immunologic and virologic data available from ACTG 315, follow-up studies of this advanced-disease population are indicated to primarily ascertain the impact of long-term suppression of viral replication on immunologic reconstitution or re-education and the durability of the antiviral effects of HAART.
NCT00000892 A Study of Several Anti-HIV Drug Combinations in HIV-Infected Patients Who Have Used Indinavir Completed National Institute of Allergy and Infectious Diseases (NIAID) N/A To compare the proportion of patients whose plasma HIV-1 RNA is below 500 copies/ml after 16 weeks of treatment. To assess the safety, toxicity, and tolerance of each treatment arm. While indinavir is currently the most commonly prescribed protease inhibitor, the optimal therapy for a person on an indinavir-containing regimen who experiences a rebound in viral load or never experiences a decrease in viral load below 500 copies per milliliter is unknown. Current clinical practice for such patients typically involves empiric use of a combination of other protease inhibitors (saquinavir/nelfinavir or saquinavir/ritonavir) and at least 1 other antiretroviral agent to which the patient has had little or no prior exposure. This may involve the use of 1 or more reverse transcriptase inhibitors (RTIs) or nonnucleoside reverse transcriptase inhibitors (NNRTIs). This study attempts to formally evaluate some of these options in indinavir-experienced patients.
NCT00000898 The Effects of Staggered Dosing on Interactions Between Paired Combinations of Nelfinavir, Ritonavir, and Saquinavir Completed National Institute of Allergy and Infectious Diseases (NIAID) N/A The purpose of this study is to see if staggering doses of nelfinavir, ritonavir, and saquinavir has any effect on the interactions between these drugs.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Saquinavir

Condition Name

Condition Name for Saquinavir
Intervention Trials
HIV Infections 73
HIV Infection 3
Pregnancy 1
Healthy 1
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Condition MeSH

Condition MeSH for Saquinavir
Intervention Trials
HIV Infections 77
Acquired Immunodeficiency Syndrome 11
Infection 11
Communicable Diseases 4
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Clinical Trial Locations for Saquinavir

Trials by Country

Trials by Country for Saquinavir
Location Trials
United States 483
Canada 24
Puerto Rico 19
Thailand 12
Spain 11
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Trials by US State

Trials by US State for Saquinavir
Location Trials
California 42
New York 40
Illinois 27
Florida 26
Massachusetts 23
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Clinical Trial Progress for Saquinavir

Clinical Trial Phase

Clinical Trial Phase for Saquinavir
Clinical Trial Phase Trials
Phase 4 18
Phase 3 11
Phase 2/Phase 3 4
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Clinical Trial Status

Clinical Trial Status for Saquinavir
Clinical Trial Phase Trials
Completed 78
Terminated 5
Withdrawn 3
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Clinical Trial Sponsors for Saquinavir

Sponsor Name

Sponsor Name for Saquinavir
Sponsor Trials
Hoffmann-La Roche 26
National Institute of Allergy and Infectious Diseases (NIAID) 21
The HIV Netherlands Australia Thailand Research Collaboration 11
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Sponsor Type

Sponsor Type for Saquinavir
Sponsor Trials
Other 52
Industry 52
NIH 31
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Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
Argus Health
QuintilesIMS
AstraZeneca
Teva
Chinese Patent Office
Cantor Fitzgerald
Express Scripts
Daiichi Sankyo

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