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Generated: December 15, 2018

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CLINICAL TRIALS PROFILE FOR NELFINAVIR MESYLATE

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Clinical Trials for Nelfinavir Mesylate

Trial ID Title Status Sponsor Phase Summary
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.
NCT00000872 Treatment With Combinations of Several Antiviral Drugs in Infants and Young Children With HIV Infection Completed Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Phase 2 This trial tests the safety and effectiveness of the early use of combinations of anti-HIV drugs in HIV-infected infants and young children in an effort to block virus growth and preserve normal immune functions. Various anti-HIV drug combinations need to be tested in order to find the best way to treat infants and children who have been infected with HIV during birth.
NCT00000872 Treatment With Combinations of Several Antiviral Drugs in Infants and Young Children With HIV Infection Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 2 This trial tests the safety and effectiveness of the early use of combinations of anti-HIV drugs in HIV-infected infants and young children in an effort to block virus growth and preserve normal immune functions. Various anti-HIV drug combinations need to be tested in order to find the best way to treat infants and children who have been infected with HIV during birth.
NCT00000885 Treatment Success and Failure in HIV-Infected Subjects Receiving Indinavir in Combination With Nucleoside Analogs: A Rollover Study for ACTG 320 Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 2 Group A: To compare the time to confirmed virologic failure (2 consecutive plasma HIV-RNA concentrations of 500 copies/ml or more) between the treatment arms: abacavir (ABC) or placebo in combination with zidovudine (ZDV), lamivudine (3TC), and indinavir (IDV). To evaluate the safety and tolerability of these treatment arms. [AS PER AMENDMENT 06/16/99: To compare the time to confirmed treatment failure, permanent discontinuation of treatment, or death between the treatment arms.] [AS PER AMENDMENT 12/27/01: Groups B, C, and D completed follow-up on March 4, 1999. Therefore, only information pertinent to Group A is applicable.] Group B: To compare the proportion of patients who achieve plasma HIV-1 RNA concentrations below 500 copies/ml, as assessed by the standard Roche Amplicor assay at Week 16, or to compare the absolute changes in plasma HIV-1 RNA concentrations at Week 16 across the treatment arms: ABC or approved nucleoside analogs and nelfinavir (NFV) or placebo in combination with efavirenz (EFV) and adefovir dipivoxil. To compare the safety and tolerability of these treatment arms. Group C: To monitor plasma HIV-1 RNA trajectory over time and determine the time to a confirmed plasma HIV-1 RNA concentration above 2,000 copies/ml on 2 consecutive determinations for patients treated with ZDV or stavudine (d4T) plus 3TC and IDV. Group D: To evaluate plasma HIV-1 RNA responses at Weeks 16 and 48. To evaluate the safety and tolerability of the treatment arms: ABC, EFV, adefovir dipivoxil, and NFV. This study explores new treatment options for ACTG 320 enrollees (and, if needed, a limited number of non-ACTG 320 volunteers) who have been receiving ZDV (or d4T) plus 3TC and IDV and are currently exhibiting a range of virologic responses. By dividing the study into the corresponding, nonsequential cohorts (Groups A, B, C, D), different approaches to evaluating virologic success, i.e., undetectable plasma HIV-1 RNA levels, and virologic failure, i.e., plasma HIV-1 RNA levels of 500 copies/ml or more [AS PER AMENDMENT 12/27/01: 200 copies/ml or more], are explored while maintaining long-term follow-up of ACTG 320 patients. [AS PER AMENDMENT 12/27/01: Groups B, C, and D completed follow-up on March 4, 1999. Therefore, only information pertinent to Group A is applicable. This study will examine the question of whether intensification of therapy can prolong the virologic benefit in individuals whose plasma HIV-1 RNA concentrations have been below the limits of assay detection on ZDV (or d4T) plus 3TC plus IDV.]
NCT00000887 A Study to Evaluate the Safety and Tolerance of Nelfinavir (NFV) Given With Zidovudine (ZDV) and Lamivudine (3TC) in HIV-Positive Pregnant Women and Their Infants Completed Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Phase 1 The purpose of this study is to see if giving nelfinavir (NFV) plus zidovudine (ZDV) plus lamivudine (3TC) to HIV-positive pregnant women and their babies is safe. This study will also look at how long these drugs stay in the blood. ZDV has been given to mothers in the past to reduce the chances of passing HIV on to their babies. However, better treatments are needed to further reduce these chances and to better suit the treatment needs of mothers and their children. Taking a combination of anti-HIV drugs during pregnancy may be an answer.
NCT00000887 A Study to Evaluate the Safety and Tolerance of Nelfinavir (NFV) Given With Zidovudine (ZDV) and Lamivudine (3TC) in HIV-Positive Pregnant Women and Their Infants Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 1 The purpose of this study is to see if giving nelfinavir (NFV) plus zidovudine (ZDV) plus lamivudine (3TC) to HIV-positive pregnant women and their babies is safe. This study will also look at how long these drugs stay in the blood. ZDV has been given to mothers in the past to reduce the chances of passing HIV on to their babies. However, better treatments are needed to further reduce these chances and to better suit the treatment needs of mothers and their children. Taking a combination of anti-HIV drugs during pregnancy may be an answer.
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.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Nelfinavir Mesylate

Condition Name

Condition Name for Nelfinavir Mesylate
Intervention Trials
HIV Infections 74
Pregnancy 2
Mycobacterium Avium-Intracellulare Infection 2
Lipodystrophy 2
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Condition MeSH

Condition MeSH for Nelfinavir Mesylate
Intervention Trials
HIV Infections 74
Infection 17
Acquired Immunodeficiency Syndrome 12
Communicable Diseases 7
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Clinical Trial Locations for Nelfinavir Mesylate

Trials by Country

Trials by Country for Nelfinavir Mesylate
Location Trials
United States 693
Puerto Rico 19
Canada 18
Switzerland 3
Italy 3
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Trials by US State

Trials by US State for Nelfinavir Mesylate
Location Trials
California 63
New York 43
Pennsylvania 37
Florida 35
Illinois 33
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Clinical Trial Progress for Nelfinavir Mesylate

Clinical Trial Phase

Clinical Trial Phase for Nelfinavir Mesylate
Clinical Trial Phase Trials
Phase 4 3
Phase 3 14
Phase 2 27
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Clinical Trial Status

Clinical Trial Status for Nelfinavir Mesylate
Clinical Trial Phase Trials
Completed 68
Unknown status 6
Recruiting 3
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Clinical Trial Sponsors for Nelfinavir Mesylate

Sponsor Name

Sponsor Name for Nelfinavir Mesylate
Sponsor Trials
National Institute of Allergy and Infectious Diseases (NIAID) 31
Agouron Pharmaceuticals 14
Glaxo Wellcome 9
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Sponsor Type

Sponsor Type for Nelfinavir Mesylate
Sponsor Trials
NIH 48
Industry 47
Other 14
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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Argus Health
Healthtrust
Dow
Mallinckrodt
Colorcon
Fuji
Farmers Insurance
Teva

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