Study of the Efficacy and Safety of Apricitabine, a New NRTI, to Treat Drug-resistant HIV Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00612898
Recruitment Status : Terminated (Sponsor decision)
First Posted : February 12, 2008
Last Update Posted : January 23, 2012
Information provided by (Responsible Party):

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: apricitabine Drug: lamivudine Phase 2 Phase 3

Detailed Description:

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.

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

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. Patients to be enrolled will be failing their current lamivudine- or emtricitabine-containing regimen and therefore have limited remaining NRTI treatment options. This study will investigate whether it is possible to improve control of HIV-1 viral replication by including ATC within a treatment experienced patient's new optimized background regimen following ART treatment failure.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 239 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : February 2008
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Lamivudine

Arm Intervention/treatment
Experimental: 1
800mg BID apricitabine plus optimised background
Drug: apricitabine
800mg BID apricitabine orally for 48 weeks
Other Name: AVX754

Active Comparator: 2
150mg BID lamivudine plus optimised background
Drug: lamivudine
150mg BID lamivudine orally for 48 weeks
Other Name: 3TC

Primary Outcome Measures :
  1. Proportion of patients with plasma HIV-1 RNA <50 copies/mL at W24 [ Time Frame: week 24 ]

Secondary Outcome Measures :
  1. Time to loss of virological response (TLOVR analysis; FDA algorithm) at W12, W24 and W48 (<50 copies/mL) [ Time Frame: week 12, 24, and 48 ]
  2. Proportion of patients with plasma HIV-1 RNA <50 copies/mL at W48 [ Time Frame: week 48 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00612898

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Sponsors and Collaborators
Study Director: Susan W Cox, Ph D Avexa Ltd
Principal Investigator: Michael Saag, MD UAB Center for AIDS Research

Responsible Party: Avexa Identifier: NCT00612898     History of Changes
Other Study ID Numbers: AVX-301
First Posted: February 12, 2008    Key Record Dates
Last Update Posted: January 23, 2012
Last Verified: January 2012

Keywords provided by Avexa:
HIV infection
Drug resistance
Reverse transcriptase inhibitor
Nucleoside analogue
treatment experienced

Additional relevant MeSH terms:
Communicable Diseases
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents