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Report for Clinical Trial NCT00612898

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase 2b/3, Randomized, Double Blind, Dose Confirming Study of the Safety, Efficacy and Tolerability of Apricitabine Versus Lamivudine in Treatment-experienced HIV-1 Infected Patients With the M184V/I Mutation in Reverse Transcriptase

Apricitabine is a new NRTI which is active against drug-resistant HIV. NRTIs are often included as part of patients' treatment, but many HIV-infected patients develop resistance to commonly used NRTIs such as lamivudine (3TC) and emtricitabine (FTC). This study will examine whether including apricitabine as part of patients' treatment is more effective than including lamivudine,when patients change treatment because of drug resistance.

NCT00612898 HIV Infections
MeSH: Infection Communicable Diseases HIV Infections Acquired Immunodeficiency Syndrome

2 Interventions

Name: apricitabine

Description: 800mg BID apricitabine orally for 48 weeks

Type: Drug

1

Name: lamivudine

Description: 150mg BID lamivudine orally for 48 weeks

Type: Drug

2


Primary Outcomes

Measure: Proportion of patients with plasma HIV-1 RNA <50 copies/mL at W24

Time: week 24

Secondary Outcomes

Measure: Time to loss of virological response (TLOVR analysis; FDA algorithm) at W12, W24 and W48 (<50 copies/mL)

Time: week 12, 24, and 48

Measure: Proportion of patients with plasma HIV-1 RNA <50 copies/mL at W48

Time: week 48

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 M184V

A Phase 2b/3, Randomized, Double Blind, Dose Confirming Study of the Safety, Efficacy and Tolerability of Apricitabine Versus Lamivudine in Treatment-experienced HIV-1 Infected Patients With the M184V/I Mutation in Reverse Transcriptase. --- M184V ---

Inclusion Criteria: - HIV-1 positive with M184V/I mutation in reverse transcriptase; - 18 years of age or older; - Currently taking lamivudine (3TC) or emtricitabine (FTC) Exclusion Criteria: - Female patients who are pregnant or breastfeeding; - Current hepatitis B virus (HBV) infection; - Current treatment for hepatitis C virus infection; - Renal function not adequate Inclusion Criteria: - HIV-1 positive with M184V/I mutation in reverse transcriptase; - 18 years of age or older; - Currently taking lamivudine (3TC) or emtricitabine (FTC) Exclusion Criteria: - Female patients who are pregnant or breastfeeding; - Current hepatitis B virus (HBV) infection; - Current treatment for hepatitis C virus infection; - Renal function not adequate HIV Infections Infection Communicable Diseases HIV Infections Acquired Immunodeficiency Syndrome ATC has potent antiviral activity both in vitro (against wild-type HIV-1 and HIV-1 with mutations in reverse transcriptase that confer resistance to NRTIs), and in clinical studies in both treatment-naïve and treatment-experienced patients with M184V, including in the presence of additional NRTI mutations in reverse transcriptase. --- M184V ---

Inclusion Criteria: - HIV-1 positive with M184V/I mutation in reverse transcriptase; - 18 years of age or older; - Currently taking lamivudine (3TC) or emtricitabine (FTC) Exclusion Criteria: - Female patients who are pregnant or breastfeeding; - Current hepatitis B virus (HBV) infection; - Current treatment for hepatitis C virus infection; - Renal function not adequate Inclusion Criteria: - HIV-1 positive with M184V/I mutation in reverse transcriptase; - 18 years of age or older; - Currently taking lamivudine (3TC) or emtricitabine (FTC) Exclusion Criteria: - Female patients who are pregnant or breastfeeding; - Current hepatitis B virus (HBV) infection; - Current treatment for hepatitis C virus infection; - Renal function not adequate HIV Infections Infection Communicable Diseases HIV Infections Acquired Immunodeficiency Syndrome ATC has potent antiviral activity both in vitro (against wild-type HIV-1 and HIV-1 with mutations in reverse transcriptase that confer resistance to NRTIs), and in clinical studies in both treatment-naïve and treatment-experienced patients with M184V, including in the presence of additional NRTI mutations in reverse transcriptase. --- M184V --- --- M184V ---

Inclusion Criteria: - HIV-1 positive with M184V/I mutation in reverse transcriptase; - 18 years of age or older; - Currently taking lamivudine (3TC) or emtricitabine (FTC) Exclusion Criteria: - Female patients who are pregnant or breastfeeding; - Current hepatitis B virus (HBV) infection; - Current treatment for hepatitis C virus infection; - Renal function not adequate Inclusion Criteria: - HIV-1 positive with M184V/I mutation in reverse transcriptase; - 18 years of age or older; - Currently taking lamivudine (3TC) or emtricitabine (FTC) Exclusion Criteria: - Female patients who are pregnant or breastfeeding; - Current hepatitis B virus (HBV) infection; - Current treatment for hepatitis C virus infection; - Renal function not adequate HIV Infections Infection Communicable Diseases HIV Infections Acquired Immunodeficiency Syndrome ATC has potent antiviral activity both in vitro (against wild-type HIV-1 and HIV-1 with mutations in reverse transcriptase that confer resistance to NRTIs), and in clinical studies in both treatment-naïve and treatment-experienced patients with M184V, including in the presence of additional NRTI mutations in reverse transcriptase. --- M184V --- --- M184V --- --- M184V ---

The M184V mutation is most commonly present amongst patients failing regimens containing either of the two deoxycytidine analogs lamivudine and emtricitabine. --- M184V ---

Whilst lamivudine therapy is often maintained in patients harboring the M184V mutation in some settings, there are no deoxycytidine analogs currently available that effectively suppress replication of HIV-1 containing the M184V/I mutation, particularly in the presence of other additional NRTI mutations. --- M184V ---

Whilst lamivudine therapy is often maintained in patients harboring the M184V mutation in some settings, there are no deoxycytidine analogs currently available that effectively suppress replication of HIV-1 containing the M184V/I mutation, particularly in the presence of other additional NRTI mutations. --- M184V --- --- M184V ---

The purpose of this study is to extend the efficacy and safety established in study AVX-201 of ATC in patients who are HIV-1 infected and have failed treatment with lamivudine or emtricitabine and have confirmed M184V/I mutation. --- M184V ---



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