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Last Updated: February 28, 2021

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CLINICAL TRIALS PROFILE FOR LAMIVUDINE

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505(b)(2) Clinical Trials for Lamivudine

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Combination NCT00002234 Safety and Effectiveness of Giving an Anti-HIV Drug Combination of Adefovir Dipivoxil Plus Didanosine Plus Efavirenz Plus Lamivudine Once Daily to HIV-Infected Patients Completed Bristol-Myers Squibb Phase 2 1969-12-31 The purpose of this study is to see if it is safe and effective to give HIV-infected patients a new combination of anti-HIV drugs taken once daily.
New Combination NCT00002234 Safety and Effectiveness of Giving an Anti-HIV Drug Combination of Adefovir Dipivoxil Plus Didanosine Plus Efavirenz Plus Lamivudine Once Daily to HIV-Infected Patients Completed Dupont Applied Biosciences Phase 2 1969-12-31 The purpose of this study is to see if it is safe and effective to give HIV-infected patients a new combination of anti-HIV drugs taken once daily.
New Combination NCT00002234 Safety and Effectiveness of Giving an Anti-HIV Drug Combination of Adefovir Dipivoxil Plus Didanosine Plus Efavirenz Plus Lamivudine Once Daily to HIV-Infected Patients Completed Glaxo Wellcome Phase 2 1969-12-31 The purpose of this study is to see if it is safe and effective to give HIV-infected patients a new combination of anti-HIV drugs taken once daily.
New Combination NCT00002234 Safety and Effectiveness of Giving an Anti-HIV Drug Combination of Adefovir Dipivoxil Plus Didanosine Plus Efavirenz Plus Lamivudine Once Daily to HIV-Infected Patients Completed Gilead Sciences Phase 2 1969-12-31 The purpose of this study is to see if it is safe and effective to give HIV-infected patients a new combination of anti-HIV drugs taken once daily.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Lamivudine

Trial ID Title Status Sponsor Phase Start Date 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 1969-12-31 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 1969-12-31 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 1969-12-31 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 1969-12-31 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.
NCT00000861 The Addition of Indinavir to Anti-HIV Treatment in HIV-Infected Patients Completed National Institute of Allergy and Infectious Diseases (NIAID) N/A 1969-12-31 The purpose of this study is to evaluate the effect of immediate versus deferred indinavir (IDV) in addition to background therapy on disease progression or death in patients with CD4+ cell counts between 200 and 500 cells/mm3 and plasma HIV RNA levels >= 10,000 copies/ml. This study aims to examine two management strategies, immediate versus deferred IDV therapy, for their clinical effects in the context of background antiretroviral (AR) therapy, given according to current clinical practice. There is an urgent need to identify the optimal use of IDV in patient management, since clinical endpoint studies have not been completed in the United States. Since there is little information about the long term durability of clinical effects, and even less information about the timing of the initiation of protease inhibitor therapy, exploring the disease progression and survival impact of immediate versus delayed use of IDV will yield important information to guide clinical decision making for this group of patients.
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.
NCT00000875 Controlled Clinical Trial of Antiviral Cytotoxic T Lymphocyte (CTL) Infusion Following Combination Antiretroviral Drug Therapy for Asymptomatic HIV-1 Infection Terminated National Institute of Allergy and Infectious Diseases (NIAID) N/A 1969-12-31 To evaluate the safety of anti-HIV CTL therapy in early stage patients and to verify the safety when combined with antiviral therapy with zidovudine/lamivudine/indinavir and low-dose interleukin-2 (IL-2). To compare the effects on plasma and cell-associated viral load following combination drug therapy with and without antiviral CTL in early-stage patients. To study in detail the immune effects of lowering viral burden with antiviral combination drugs with and without T cell infusion on antiviral CTL activity, viral suppression and proliferation, circulating T cell phenotype, T cell apoptosis, CD4 cell numbers, DTH reaction, and inflammatory cytokine levels. In an HIV-infected person, there is an ongoing struggle between HIV replication and host immune control. In the past decade most therapeutic strategies have targeted the virus. This approach has been frustrated by viral mutation to evade drug sensitivity. Promising drugs have recently been approved and there are encouraging sustained results from combination antiviral chemotherapy. However, even the most potent drug regimens do not seem to be curative, may eventually lead to drug resistance and may not completely restore lost immune function. The addition of immune-based therapy to antiviral drugs may lead to better viral control.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Lamivudine

Condition Name

Condition Name for Lamivudine
Intervention Trials
HIV Infections 250
Chronic Hepatitis B 52
HIV 44
HIV Infection 36
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Condition MeSH

Condition MeSH for Lamivudine
Intervention Trials
HIV Infections 334
Hepatitis B 123
Hepatitis 121
Hepatitis A 103
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Clinical Trial Locations for Lamivudine

Trials by Country

Trials by Country for Lamivudine
Location Trials
Germany 91
Italy 71
Puerto Rico 70
United Kingdom 59
France 53
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Trials by US State

Trials by US State for Lamivudine
Location Trials
California 162
New York 137
Florida 124
Texas 108
Illinois 107
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Clinical Trial Progress for Lamivudine

Clinical Trial Phase

Clinical Trial Phase for Lamivudine
Clinical Trial Phase Trials
Phase 4 174
Phase 3 149
Phase 2/Phase 3 16
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Clinical Trial Status

Clinical Trial Status for Lamivudine
Clinical Trial Phase Trials
Completed 337
Recruiting 62
Unknown status 51
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Clinical Trial Sponsors for Lamivudine

Sponsor Name

Sponsor Name for Lamivudine
Sponsor Trials
National Institute of Allergy and Infectious Diseases (NIAID) 100
GlaxoSmithKline 63
ViiV Healthcare 47
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Sponsor Type

Sponsor Type for Lamivudine
Sponsor Trials
Other 558
Industry 354
NIH 137
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