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Generated: December 13, 2018

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CLINICAL TRIALS PROFILE FOR STAVUDINE

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Clinical Trials for Stavudine

Trial ID Title Status Sponsor Phase Summary
NCT00000789 A Randomized, Comparative Trial of Zidovudine (AZT) Versus 2',3'-Didehydro-3'-Deoxythymidine (Stavudine; d4T) in Children With HIV Infection Completed Bristol-Myers Squibb Phase 2 PRIMARY: To compare the relative safety and tolerance of oral zidovudine (AZT) versus oral stavudine (d4T) in symptomatic HIV-infected children. SECONDARY: To compare the clinical, virologic, and immunologic responses between the two treatment groups, and to obtain pharmacokinetic data for both drugs. At present, AZT is considered the drug of choice for initial treatment of most children with HIV infection, although disease progression or drug intolerance is associated with its long-term use. In preliminary studies in children, d4T, another HIV inhibitor, has been well tolerated, although an optimum dose has not been determined.
NCT00000789 A Randomized, Comparative Trial of Zidovudine (AZT) Versus 2',3'-Didehydro-3'-Deoxythymidine (Stavudine; d4T) in Children With HIV Infection Completed Glaxo Wellcome Phase 2 PRIMARY: To compare the relative safety and tolerance of oral zidovudine (AZT) versus oral stavudine (d4T) in symptomatic HIV-infected children. SECONDARY: To compare the clinical, virologic, and immunologic responses between the two treatment groups, and to obtain pharmacokinetic data for both drugs. At present, AZT is considered the drug of choice for initial treatment of most children with HIV infection, although disease progression or drug intolerance is associated with its long-term use. In preliminary studies in children, d4T, another HIV inhibitor, has been well tolerated, although an optimum dose has not been determined.
NCT00000789 A Randomized, Comparative Trial of Zidovudine (AZT) Versus 2',3'-Didehydro-3'-Deoxythymidine (Stavudine; d4T) in Children With HIV Infection Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 2 PRIMARY: To compare the relative safety and tolerance of oral zidovudine (AZT) versus oral stavudine (d4T) in symptomatic HIV-infected children. SECONDARY: To compare the clinical, virologic, and immunologic responses between the two treatment groups, and to obtain pharmacokinetic data for both drugs. At present, AZT is considered the drug of choice for initial treatment of most children with HIV infection, although disease progression or drug intolerance is associated with its long-term use. In preliminary studies in children, d4T, another HIV inhibitor, has been well tolerated, although an optimum dose has not been determined.
NCT00000838 Antiviral Activity of and Resistance to Lamivudine in Combination With Zidovudine, Stavudine, or Didanosine Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 2 To evaluate the efficacy, safety, and pharmacokinetics of lamivudine (3TC) combined with zidovudine (AZT), stavudine (d4T), or didanosine (ddI) in comparison with d4T or ddI monotherapy in HIV-infected patients with no prior nucleoside therapy. 3TC may be uniquely effective in combination with AZT due to the interaction of AZT and 3TC resistance mutations. One explanation is that the M184V mutation, which confers resistance to 3TC, suppresses AZT resistance. This benefit of 3TC may not extend to combination therapy with other nucleoside analogs.
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.
NCT00000842 A Phase II, Double-Blind Trial of Recombinant Human Nerve Growth Factor for Treatment of HIV-Associated Sensory Neuropathy Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 2 To assess the efficacy, safety, and tolerability of recombinant human nerve growth factor ( rhNGF ) in the treatment of HIV-associated sensory neuropathy. AS PER AMENDMENT 5/6/97: To compare the change in viral load between the double-blind phase baseline and week 4 in placebo and active rhNGF recipients. To ensure that rhNGF does not induce an increase in viral load compared with viral load changes seen with placebo. Up to now, treatments for HIV-associated sensory neuropathy have been symptomatic, relying on pain-modifying agents or membrane-stabilizing drugs. Because nerve growth factor is important in the development and maintenance of sympathetic and sensory neurons and their outgrowths, it is proposed that recombinant human nerve growth factor may provide a specific restorative treatment for HIV-associated painful sensory neuropathy.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Stavudine

Condition Name

Condition Name for Stavudine
Intervention Trials
HIV Infections 129
HIV 8
AIDS 5
Tuberculosis 4
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Condition MeSH

Condition MeSH for Stavudine
Intervention Trials
HIV Infections 137
Infection 27
Acquired Immunodeficiency Syndrome 24
Communicable Diseases 11
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Clinical Trial Locations for Stavudine

Trials by Country

Trials by Country for Stavudine
Location Trials
United States 948
Puerto Rico 37
Canada 22
South Africa 18
Thailand 9
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Trials by US State

Trials by US State for Stavudine
Location Trials
California 81
New York 68
Illinois 53
Florida 52
Massachusetts 47
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Clinical Trial Progress for Stavudine

Clinical Trial Phase

Clinical Trial Phase for Stavudine
Clinical Trial Phase Trials
Phase 4 26
Phase 3 27
Phase 2/Phase 3 6
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Clinical Trial Status

Clinical Trial Status for Stavudine
Clinical Trial Phase Trials
Completed 130
Unknown status 10
Terminated 6
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Clinical Trial Sponsors for Stavudine

Sponsor Name

Sponsor Name for Stavudine
Sponsor Trials
National Institute of Allergy and Infectious Diseases (NIAID) 53
Bristol-Myers Squibb 23
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) 10
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Sponsor Type

Sponsor Type for Stavudine
Sponsor Trials
Industry 78
NIH 70
Other 65
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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
QuintilesIMS
US Army
UBS
Mallinckrodt
Accenture
McKesson
Farmers Insurance
Julphar

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