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Last Updated: October 15, 2019

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CLINICAL TRIALS PROFILE FOR ABACAVIR SULFATE

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Clinical Trials for Abacavir Sulfate

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00001086 A Study of Abacavir Plus Indinavir Sulfate Plus Efavirenz in HIV-Infected Patients Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 2 1969-12-31 To compare the virologic response between abacavir (ABC, 1592U89) regimens (drug vs. placebo) and between the 2 dosing regimens (BID vs. TID) with respect to the proportion of patients with plasma HIV RNA levels below the limit of detection [AS PER AMENDMENT 8/27/97: < 500 copies/ml at week 16]. To evaluate the safety and tolerance of the study arms. [AS PER AMENDMENT 3/10/99: During the extension period, compare the time to detectable viremia (2 consecutive plasma HIV RNA levels greater than or equal to 500 copies/ml) between ABC and placebo.] Therapeutically, there is a need to explore potent alternative therapy for patients who have received, or are currently receiving, a double nucleoside analog combination including lamivudine (3TC), a regimen that was proven to be clinically inferior to indinavir (IDV) when combined with zidovudine/3TC in study ACTG 320. In order to produce and maintain a maximal antiviral response, all patients in this study will receive 2 or 3 potent, new agents; ABC, a nucleoside analog, EFV, a non-nucleoside reverse transcriptase inhibitor (NNRTI), and IDV, a protease inhibitor. Virologically, the major question this protocol seeks to answer is how prior 3TC exposure in a dual nucleoside regimen influences the response to subsequent treatment. It is unclear whether it is best to add a protease inhibitor either 1) an NNRTI at 1 of 2 doses, or 2) an NNRTI at 1 of 2 doses plus a new nucleoside analog to achieve plasma HIV RNA levels that are below the limits of detection.
NCT00078247 Anti-HIV Drugs for Ugandan Patients With HIV and Tuberculosis Completed Makerere University Phase 3 2004-10-01 This study is designed to determine whether 6 months of anti-HIV drugs given along with tuberculosis treatment will delay the onset of AIDS in HIV infected African patients.
NCT00078247 Anti-HIV Drugs for Ugandan Patients With HIV and Tuberculosis Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 3 2004-10-01 This study is designed to determine whether 6 months of anti-HIV drugs given along with tuberculosis treatment will delay the onset of AIDS in HIV infected African patients.
NCT00084149 Safety of and Immune Response to Cyclosporine A in Combination With Abacavir Sulfate, Lamivudine, and Zidovudine and Lopinavir/Ritonavir in Adults With Acute HIV Infection Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 2 2004-02-01 Cyclosporine A (CsA) is a common long-term treatment used to inhibit the immune response in transplant patients who receive donor organs. CsA may also help people with HIV. The purpose of this study is to determine the safety of and immune response to CsA when given with abacavir sulfate, lamivudine, and zidovudine (ABC/3TC/AZT) and lopinavir/ritonavir (LPV/r) to HIV infected adults in the early stages of infection. Study hypothesis: The combination of CsA and LPV/r given to acutely infected individuals will result in lower levels of proviral DNA and latent infectious virus at 48 weeks compared to acute infected individuals treated with LPV/r alone.
NCT00102206 A Comparison of Two Anti-HIV Drug Regimens for Youth Who Have Failed Prior Therapy Completed Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Phase 2 1969-12-31 HIV infected children and adolescents who have taken many anti-HIV drugs may have limited treatment options and are at high risk for progressing to AIDS. The purpose of this study is to determine whether an anti-HIV treatment regimen of 2 protease inhibitors (PIs) and 2 nucleoside reverse transcriptase inhibitors (NRTIs) is more effective than a regimen of 4 NRTIs in treatment-experienced children and adolescents who have failed previous anti-HIV treatment.
NCT00102206 A Comparison of Two Anti-HIV Drug Regimens for Youth Who Have Failed Prior Therapy Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 2 1969-12-31 HIV infected children and adolescents who have taken many anti-HIV drugs may have limited treatment options and are at high risk for progressing to AIDS. The purpose of this study is to determine whether an anti-HIV treatment regimen of 2 protease inhibitors (PIs) and 2 nucleoside reverse transcriptase inhibitors (NRTIs) is more effective than a regimen of 4 NRTIs in treatment-experienced children and adolescents who have failed previous anti-HIV treatment.
NCT00102960 Anti-HIV Drugs for Treating Infants Who Acquired HIV Infection at Birth Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 3 2005-07-01 The purpose of this study is to compare the effects of anti-HIV drug courses of different lengths in infants who became HIV infected at birth.
>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 6
HIV Infection 2
Infection, Human Immunodeficiency Virus 1
HIV 1
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Condition MeSH

Condition MeSH for Abacavir Sulfate
Intervention Trials
HIV Infections 10
Acquired Immunodeficiency Syndrome 4
Infection 3
Communicable Diseases 3
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Clinical Trial Locations for Abacavir Sulfate

Trials by Country

Trials by Country for Abacavir Sulfate
Location Trials
United States 73
Canada 5
Mexico 4
Puerto Rico 3
Uganda 1
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Trials by US State

Trials by US State for Abacavir Sulfate
Location Trials
North Carolina 5
New York 5
Illinois 4
Florida 4
District of Columbia 3
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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 2
Phase 3 3
Phase 2 4
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Clinical Trial Status

Clinical Trial Status for Abacavir Sulfate
Clinical Trial Phase Trials
Completed 10
Recruiting 1
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Clinical Trial Sponsors for Abacavir Sulfate

Sponsor Name

Sponsor Name for Abacavir Sulfate
Sponsor Trials
National Institute of Allergy and Infectious Diseases (NIAID) 6
ViiV Healthcare 2
GlaxoSmithKline 2
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Sponsor Type

Sponsor Type for Abacavir Sulfate
Sponsor Trials
NIH 8
Industry 6
Other 3
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Serving leading biopharmaceutical companies globally:

Colorcon
Mallinckrodt
Moodys
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Boehringer Ingelheim

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