Study of Once Daily Elvucitabine Versus Lamivudine in Participants With a Documented M184V Mutation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2007-10-31

Brief Summary

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Human immunodeficiency virus (HIV)-1 infected participants receiving long-term therapy with lamivudine or emtricitabine (nucleoside reverse transcriptase inhibitors \[NRTIs\]) are at risk for the development of a mutation at position M184 on the HIV reverse transcriptase gene. This mutation confers resistance to both drugs (\>100 fold increase in the concentration of drug producing 50% inhibition \[IC50\]).

In-vitro studies with elvucitabine have shown that HIV-1 isolates with the M184V mutation show only a 10-fold increase in IC50 as compared to wild type HIV-1. Alexion Pharmaceuticals Inc. intention is to demonstrate that 10 milligrams (mg) of elvucitabine, administered once per day for 14 days with continued background anti-HIV-1 medications, will demonstrate a fall in HIV-1 ribonucleic acid (RNA) plasma levels, as compared to baseline. The data from this study will guide dosing in future long-term studies in HIV-1 infected participants with the M184V mutation.

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Detailed Description

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This was a Phase 2a, 14-Day randomized, double-blind, comparative viral kinetic study of10 mg elvucitabine as compared to lamivudine that was administered once daily (QD) to HIV-1 infected participants with a documented M184V variant. This study also demonstrated the antiviral activity as well as the assessment of safety of the elvucitabine therapy

Participants must be receiving a stable antiretroviral regimen (defined as no change in antiretroviral therapy for at least 4 weeks prior to randomization) that includes lamivudine or emtricitabine. At 72 hours prior to randomization, only lamivudine or emtricitabine will be stopped for washout; participants will continue to receive the other drugs in their prescribed regimen (background antiretroviral therapy) during the 72-hour washout period. Participants will then be randomized to receive blinded elvucitabine or lamivudine in a 1:1 ratio and continue to receive their prescribed background antiretroviral therapy for 14 days on an outpatient basis. Participants will be followed for an additional 14 days post-treatment for safety unless they enroll in the ACH443-018 extension study where they will continue to be treated and followed for safety.

Conditions

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HIV Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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A

Group Type EXPERIMENTAL

Elvucitabine

Intervention Type DRUG

Elvucitabine 10 mg QD for 14days

B

Group Type ACTIVE_COMPARATOR

Lamivudine

Intervention Type DRUG

Lamivudine 300 mg QD for 14 days

Interventions

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Elvucitabine

Elvucitabine 10 mg QD for 14days

Intervention Type DRUG

Lamivudine

Lamivudine 300 mg QD for 14 days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Clinically stable HIV-1 infected participants
* Ages \>18 and \<65 years
* Documented M184V mutation
* CD4 cell count \>100 cells/mL
* Plasma HIV-1 RNA levels \>5000 and \<150,000 copies/milliliter (mL)
* Currently receiving lamivudine or emtricitabine
* Other hematologic and metabolic parameters must be met.
* Provide written informed consent

Exclusion Criteria

* Hepatitis B antigen positive
* HIV-1 genotype positive for more than or equal to 4 protease mutations
* HIV-1 genotype positive for more than or equal to 2 non-nucleoside reverse transcriptase inhibitor (NNRTI) mutations
* Previous therapy with cytotoxic or myelosuppressive drugs in the past 3 months
* Evidence or history of cirrhosis
* Women who are pregnant or breast feeding

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No