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Generated: December 12, 2018

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CLINICAL TRIALS PROFILE FOR LAMIVUDINE; ZIDOVUDINE

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Clinical Trials for Lamivudine; Zidovudine

Trial ID Title Status Sponsor Phase Summary
NCT00000831 Virologic Responses To New Nucleoside Regimens After Prolonged ZDV or ddI Monotherapy Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 2 To elucidate the relationship between virologic risk factors and immunologic and clinical progression in patients receiving monotherapy in protocol ACTG 175, and to compare new treatment regimens with combinations of reverse transcriptase inhibitors in long-term recipients of monotherapy. Specifically, to determine, in patients who have been taking zidovudine (AZT) alone for a long time, whether it is beneficial to add lamivudine (3TC) to AZT or to switch to d4T alone, and also to determine, in patients who have been taking didanosine (ddI) alone for a long time, whether it is beneficial to add AZT or AZT/3TC to ddI. Characteristics of virus replication, pathogenicity, and resistance are thought to determine the durability of virologic and clinical response to nucleoside reverse transcriptase inhibitors. Previous results of ACTG 175 suggest that either a switch to ddI or addition of ddI in patients receiving AZT results in better clinical, virologic, and CD4 cell response compared to continuation of AZT alone.
NCT00000834 A Phase I Study of Methotrexate for HIV Infection Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 1 To determine the safety and tolerance of methotrexate in HIV-infected patients. To determine the dose effective in modulating key markers of immune activation. To determine a dose suitable for Phase II or III evaluation in HIV-infected patients. In HIV infection, complete immunological clearance of the foreign antigen does not occur, resulting in chronic immune activation. Because chronic immune activation may contribute to disease progression in HIV infection, immunomodulators may have therapeutic value in early HIV disease prior to development of opportunistic infections. The clinical benefits of methotrexate appear to derive from an anti-inflammatory effect; thus, it may reduce the state of chronic immune activation.
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.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Lamivudine; Zidovudine

Condition Name

Condition Name for Lamivudine; Zidovudine
Intervention Trials
HIV Infections 129
HIV 18
HIV Infection 10
Pregnancy 5
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Condition MeSH

Condition MeSH for Lamivudine; Zidovudine
Intervention Trials
HIV Infections 145
Acquired Immunodeficiency Syndrome 28
Infection 27
Communicable Diseases 13
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Clinical Trial Locations for Lamivudine; Zidovudine

Trials by Country

Trials by Country for Lamivudine; Zidovudine
Location Trials
Puerto Rico 41
Canada 40
Spain 34
South Africa 27
India 16
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Trials by US State

Trials by US State for Lamivudine; Zidovudine
Location Trials
California 84
New York 68
Illinois 59
Florida 58
North Carolina 53
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Clinical Trial Progress for Lamivudine; Zidovudine

Clinical Trial Phase

Clinical Trial Phase for Lamivudine; Zidovudine
Clinical Trial Phase Trials
Phase 4 36
Phase 3 43
Phase 2/Phase 3 7
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Clinical Trial Status

Clinical Trial Status for Lamivudine; Zidovudine
Clinical Trial Phase Trials
Completed 145
Unknown status 12
Recruiting 11
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Clinical Trial Sponsors for Lamivudine; Zidovudine

Sponsor Name

Sponsor Name for Lamivudine; Zidovudine
Sponsor Trials
National Institute of Allergy and Infectious Diseases (NIAID) 67
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) 19
Glaxo Wellcome 16
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Sponsor Type

Sponsor Type for Lamivudine; Zidovudine
Sponsor Trials
Other 132
NIH 92
Industry 92
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Serving hundreds of leading biopharmaceutical companies globally:

US Army
Federal Trade Commission
AstraZeneca
Johnson and Johnson
Daiichi Sankyo
Queensland Health
UBS
Cerilliant
Chubb

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