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Last Updated: November 22, 2024

CLINICAL TRIALS PROFILE FOR ABACAVIR SULFATE


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All Clinical Trials for ABACAVIR SULFATE

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000864 ↗ A Study to Test the Safety, Tolerance, and Metabolism of Abacavir (1592U89, ABC) With Standard Zidovudine (ZDV) Therapy in Newborn Infants Born to HIV-1 Infected Women Completed Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Phase 1 1969-12-31 The purpose of this study is to determine the safety, tolerance, and metabolism of single-dose and multiple-dose abacavir (ABC) in HIV-exposed infants receiving standard postnatal treatment with zidovudine (ZDV). This study also evaluates the correct dosages of ABC to be used in future studies. Early aggressive therapy may be the best chance to slow disease progression in infants who may have been infected with HIV by their mothers. Early HIV suppression may significantly reduce viral levels and allow for restoration of the immune system, providing improved control over HIV infection. Therefore, it is important that the safety and tolerance of ABC in combination with ZDV be examined as potential early therapy in newborn and young infants.
NCT00000864 ↗ A Study to Test the Safety, Tolerance, and Metabolism of Abacavir (1592U89, ABC) With Standard Zidovudine (ZDV) Therapy in Newborn Infants Born to HIV-1 Infected Women Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 1 1969-12-31 The purpose of this study is to determine the safety, tolerance, and metabolism of single-dose and multiple-dose abacavir (ABC) in HIV-exposed infants receiving standard postnatal treatment with zidovudine (ZDV). This study also evaluates the correct dosages of ABC to be used in future studies. Early aggressive therapy may be the best chance to slow disease progression in infants who may have been infected with HIV by their mothers. Early HIV suppression may significantly reduce viral levels and allow for restoration of the immune system, providing improved control over HIV infection. Therefore, it is important that the safety and tolerance of ABC in combination with ZDV be examined as potential early therapy in newborn and young infants.
NCT00000865 ↗ The Safety and Effects of 1592U89 Used Alone or in Combination With Other Anti-HIV Drugs in HIV-Infected Infants and Children Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 1 1969-12-31 To assess the steady state pharmacokinetic features, tolerance, and safety of orally administered 1592U89, given alone or in combination with other antiretroviral medications, in HIV infected infants and children. To establish doses of 1592U89 appropriate for future pediatric Phase II/III clinical trials. On the basis of the preclinical and clinical studies, 1592U89 appears to be a promising agent for treatment of HIV infection in children, either as an alternative to currently employed agents, or in combination therapy regimens. A liquid formulation of the drug is available; thus concurrent development of 1592U89 for children and adults is possible.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for ABACAVIR SULFATE

Condition Name

Condition Name for ABACAVIR SULFATE
Intervention Trials
HIV Infections 59
Lipodystrophy 3
HIV 2
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Condition MeSH

Condition MeSH for ABACAVIR SULFATE
Intervention Trials
HIV Infections 63
Infections 21
Infection 21
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Clinical Trial Locations for ABACAVIR SULFATE

Trials by Country

Trials by Country for ABACAVIR SULFATE
Location Trials
United States 499
Puerto Rico 11
Canada 10
Mexico 4
Italy 2
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Trials by US State

Trials by US State for ABACAVIR SULFATE
Location Trials
New York 42
California 38
North Carolina 33
Illinois 30
Florida 27
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Clinical Trial Progress for ABACAVIR SULFATE

Clinical Trial Phase

Clinical Trial Phase for ABACAVIR SULFATE
Clinical Trial Phase Trials
Phase 4 8
Phase 3 15
Phase 2 20
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Clinical Trial Status

Clinical Trial Status for ABACAVIR SULFATE
Clinical Trial Phase Trials
Completed 58
Unknown status 4
Withdrawn 2
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Clinical Trial Sponsors for ABACAVIR SULFATE

Sponsor Name

Sponsor Name for ABACAVIR SULFATE
Sponsor Trials
Glaxo Wellcome 30
National Institute of Allergy and Infectious Diseases (NIAID) 27
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) 5
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Sponsor Type

Sponsor Type for ABACAVIR SULFATE
Sponsor Trials
Industry 43
NIH 33
Other 6
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