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Last Updated: June 30, 2022

CLINICAL TRIALS PROFILE FOR STAVUDINE


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All Clinical Trials for Stavudine

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000686 ↗ A Study of d4T in Patients With AIDS or AIDS-Related Complex Who Cannot Take AZT Terminated Bristol-Myers Squibb Phase 1 1969-12-31 To determine the safety and maximum tolerated dose (MTD) of 2',3'-dideoxy-2',3'-didehydrothymidine (d4T) administered to patients with AIDS or AIDS related complex (ARC) who are intolerant of zidovudine (AZT). The study also begins an assessment of the effectiveness of d4T therapy on HIV replication, on plasma levels of p24 antigen, and clinical or immunologic parameters associated with AIDS. Of the methods that are being evaluated to treat HIV-infected individuals, AZT has produced the best results to date. Toxic effects in approximately 50 percent of patients receiving AZT may limit its usefulness for prolonged treatment. Long-term treatment may be necessary to prevent progression of early stage HIV infection to AIDS and to prevent secondary transmission. Other drugs that may be equally or more effective than AZT and useful in the long- term treatment of HIV infection must be developed and evaluated. Test-tube and animal studies of d4T show that the drug can inhibit replication (reproduction) of HIV at concentrations similar to concentrations of AZT that have anti-HIV activity. These studies also indicate that the drug may stay in the bloodstream longer than AZT. Thus, it may be possible for the drug to be as effective as AZT when taken less frequently than AZT. It also may have a less disturbing effect on other body functions (such as thymidine metabolism).
NCT00000686 ↗ A Study of d4T in Patients With AIDS or AIDS-Related Complex Who Cannot Take AZT Terminated National Institute of Allergy and Infectious Diseases (NIAID) Phase 1 1969-12-31 To determine the safety and maximum tolerated dose (MTD) of 2',3'-dideoxy-2',3'-didehydrothymidine (d4T) administered to patients with AIDS or AIDS related complex (ARC) who are intolerant of zidovudine (AZT). The study also begins an assessment of the effectiveness of d4T therapy on HIV replication, on plasma levels of p24 antigen, and clinical or immunologic parameters associated with AIDS. Of the methods that are being evaluated to treat HIV-infected individuals, AZT has produced the best results to date. Toxic effects in approximately 50 percent of patients receiving AZT may limit its usefulness for prolonged treatment. Long-term treatment may be necessary to prevent progression of early stage HIV infection to AIDS and to prevent secondary transmission. Other drugs that may be equally or more effective than AZT and useful in the long- term treatment of HIV infection must be developed and evaluated. Test-tube and animal studies of d4T show that the drug can inhibit replication (reproduction) of HIV at concentrations similar to concentrations of AZT that have anti-HIV activity. These studies also indicate that the drug may stay in the bloodstream longer than AZT. Thus, it may be possible for the drug to be as effective as AZT when taken less frequently than AZT. It also may have a less disturbing effect on other body functions (such as thymidine metabolism).
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 1969-12-31 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 1969-12-31 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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Stavudine

Condition Name

Condition Name for Stavudine
Intervention Trials
HIV Infections 148
HIV 8
Aids 5
Lipodystrophy 5
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Condition MeSH

Condition MeSH for Stavudine
Intervention Trials
HIV Infections 158
Infections 32
Infection 30
Acquired Immunodeficiency Syndrome 28
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Clinical Trial Locations for Stavudine

Trials by Country

Trials by Country for Stavudine
Location Trials
Puerto Rico 41
Canada 27
South Africa 19
Thailand 10
Brazil 9
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Trials by US State

Trials by US State for Stavudine
Location Trials
California 93
New York 81
Illinois 64
Florida 61
Massachusetts 59
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Clinical Trial Progress for Stavudine

Clinical Trial Phase

Clinical Trial Phase for Stavudine
Clinical Trial Phase Trials
Phase 4 29
Phase 3 31
Phase 2/Phase 3 6
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Clinical Trial Status

Clinical Trial Status for Stavudine
Clinical Trial Phase Trials
Completed 152
Unknown status 10
Terminated 7
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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) 65
Bristol-Myers Squibb 27
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) 12
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Sponsor Type

Sponsor Type for Stavudine
Sponsor Trials
Industry 88
NIH 87
Other 69
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