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Generated: December 19, 2018

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CLINICAL TRIALS PROFILE FOR INDINAVIR SULFATE

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Clinical Trials for Indinavir Sulfate

Trial ID Title Status Sponsor Phase Summary
NCT00000804 A Randomized Trial of L-735,524, An Inhibitor of the HIV Protease Enzyme, and Interleukin-2 in Persons Infected With HIV (NOTE: Only For Patients Who Previously Completed NIAID 93 CC-113) Withdrawn National Institute of Allergy and Infectious Diseases (NIAID) N/A The purpose of this trial is to study L-735,524, which is an inhibitor of the HIV protease enzyme. It will be used with interleukin-2 in patients infected with HIV.
NCT00000841 A Study of Indinavir Sulfate Plus Zidovudine (AZT) Plus Lamivudine in HIV-Infected Patients Who Have Taken AZT for Six or More Months Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 3 To determine the clinical efficacy of indinavir sulfate or placebo in combination with zidovudine ( AZT ) and lamivudine ( 3TC ) in AIDS patients. Protease inhibitors such as indinavir sulfate may be effective in patients with advanced HIV disease who have received prior AZT therapy. Since studies suggest that triple drug therapy may have an advantage over both monotherapy and two drug therapy, the combination of indinavir sulfate with AZT and 3TC should be evaluated.
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.
NCT00000850 The Effectiveness of GM-CSF in HIV-Positive Patients Who Are Also Receiving Anti-HIV Therapy Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 2 The purpose of this study is to see how HIV-positive patients who are taking anti-HIV drugs and have a viral load (level of HIV in the blood) of 1,500 copies/ml or more respond to GM-CSF (granulocyte-macrophage colony-stimulating factor). GM-CSF is a medication that is being tested in HIV-positive patients to see if it can improve their immune systems or if it can lower the level of HIV in their blood. GM-CSF is often given to patients with leukemia or patients who have received bone marrow transplants to increase their white blood cells and to improve their immune systems. Doctors believe that GM-CSF can increase CD4 counts in HIV-positive patients, but this study will also look at how GM-CSF affects viral load.
NCT00000859 A Randomized Trial of the Efficacy and Safety of a Strategy of Starting With Nelfinavir Versus Ritonavir Added to Background Antiretroviral (AR) Nucleoside Therapy in HIV-Infected Individuals With CD4+ Cell Counts Less Than or Equal to 200/mm3 Completed National Institute of Allergy and Infectious Diseases (NIAID) N/A To compare nelfinavir (NFV) with ritonavir (RTV) for delaying disease progression or death in HIV-infected patients with CD4+ cell counts less than 100 cells/mm3 [AS PER AMENDMENT 3/11/98: less than or equal to 200 cells/mm3]. To compare NFV with RTV for the development of adverse events and for rates of permanent discontinuation of study medication. [AS PER AMENDMENT 10/02/97: To compare by intention-to-treat analysis for disease progression, including death, the following two regimens: NFV plus background combination antiretroviral (AR) therapy followed by indinavir (IDV) or RTV in the event of significant intolerance; and RTV plus AR therapy followed by IDV, then NFV, in the event of significant intolerance.] [AS PER AMENDMENT 3/11/98: SUBSTUDY CPCRA 045: To determine the relative rates of emergence of HIV-1 resistance and to compare changes in plasma HIV RNA levels and CD4+ cell counts in a sample of patients with CD4+ cell counts <= 200/mm3 who are enrolled in protocol CPCRA 042.] AR therapy is rapidly becoming the standard of care for the treatment of HIV infection. AR therapy provides the best opportunity for maximizing viral suppression, reducing toxicity and delaying the emergence of resistant strains. The newest class of AR agents, the HIV protease inhibitors, exhibits the most potent anti-HIV effects described to date. This study will compare 2 protease inhibitors, NFV and RTV for efficacy and safety in a population with advanced HIV disease, who are taking various background nucleoside therapies.
NCT00000861 The Addition of Indinavir to Anti-HIV Treatment in HIV-Infected Patients Completed National Institute of Allergy and Infectious Diseases (NIAID) N/A The purpose of this study is to evaluate the effect of immediate versus deferred indinavir (IDV) in addition to background therapy on disease progression or death in patients with CD4+ cell counts between 200 and 500 cells/mm3 and plasma HIV RNA levels >= 10,000 copies/ml. This study aims to examine two management strategies, immediate versus deferred IDV therapy, for their clinical effects in the context of background antiretroviral (AR) therapy, given according to current clinical practice. There is an urgent need to identify the optimal use of IDV in patient management, since clinical endpoint studies have not been completed in the United States. Since there is little information about the long term durability of clinical effects, and even less information about the timing of the initiation of protease inhibitor therapy, exploring the disease progression and survival impact of immediate versus delayed use of IDV will yield important information to guide clinical decision making for this group of patients.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Indinavir Sulfate

Condition Name

Condition Name for Indinavir Sulfate
Intervention Trials
HIV Infections 78
Acquired Immunodeficiency Syndrome 1
Hypertension 1
Hemophilia A 1
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Condition MeSH

Condition MeSH for Indinavir Sulfate
Intervention Trials
HIV Infections 78
Infection 16
Acquired Immunodeficiency Syndrome 9
Communicable Diseases 8
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Clinical Trial Locations for Indinavir Sulfate

Trials by Country

Trials by Country for Indinavir Sulfate
Location Trials
United States 713
Puerto Rico 20
Canada 14
Italy 1
Switzerland 1
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Trials by US State

Trials by US State for Indinavir Sulfate
Location Trials
California 59
New York 55
Illinois 38
Pennsylvania 35
Massachusetts 35
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Clinical Trial Progress for Indinavir Sulfate

Clinical Trial Phase

Clinical Trial Phase for Indinavir Sulfate
Clinical Trial Phase Trials
Phase 4 3
Phase 3 12
Phase 2 30
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Clinical Trial Status

Clinical Trial Status for Indinavir Sulfate
Clinical Trial Phase Trials
Completed 71
Unknown status 5
Withdrawn 2
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Clinical Trial Sponsors for Indinavir Sulfate

Sponsor Name

Sponsor Name for Indinavir Sulfate
Sponsor Trials
National Institute of Allergy and Infectious Diseases (NIAID) 37
Merck Sharp & Dohme Corp. 20
Glaxo Wellcome 7
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Sponsor Type

Sponsor Type for Indinavir Sulfate
Sponsor Trials
NIH 43
Industry 40
Other 4
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Serving hundreds of leading biopharmaceutical companies globally:

McKesson
Accenture
Harvard Business School
Daiichi Sankyo
McKinsey
Boehringer Ingelheim
Mallinckrodt
Argus Health
Federal Trade Commission

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