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

This study has been terminated.
(Sponsor decision)
Sponsor:
Information provided by (Responsible Party):
Avexa
ClinicalTrials.gov Identifier:
NCT00612898
First received: January 30, 2008
Last updated: January 19, 2012
Last verified: January 2012

January 30, 2008
January 19, 2012
February 2008
January 2010   (final data collection date for primary outcome measure)
Proportion of patients with plasma HIV-1 RNA <50 copies/mL at W24 [ Time Frame: week 24 ] [ Designated as safety issue: No ]
1. Proportion of patients with plasma HIV-1 RNA <400 copies/mL at W24 [ Time Frame: week 24 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00612898 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • Proportion of patients with plasma HIV-1 RNA <50 copies/mL at W48 [ Time Frame: week 48 ] [ Designated as safety issue: No ]
  • 2. Time to loss of virological response (TLOVR analysis; FDA algorithm) at W12, W24 and W48 (<400 copies/mL) [ Time Frame: Week 12, 24, and 48 ] [ Designated as safety issue: No ]
  • 1. Proportion of patients with plasma HIV-1 RNA <400 copies/mL at W48 [ Time Frame: week 48 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Study of the Efficacy and Safety of Apricitabine, a New NRTI, to Treat Drug-resistant HIV Infection
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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
HIV Infections
  • Drug: apricitabine
    800mg BID apricitabine orally for 48 weeks
    Other Name: AVX754
  • Drug: lamivudine
    150mg BID lamivudine orally for 48 weeks
    Other Name: 3TC
  • Experimental: 1
    800mg BID apricitabine plus optimised background
    Intervention: Drug: apricitabine
  • Active Comparator: 2
    150mg BID lamivudine plus optimised background
    Intervention: Drug: lamivudine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
239
January 2010
January 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Belgium,   Canada,   Germany,   Israel,   Italy,   Peru,   Puerto Rico,   Thailand,   United Kingdom
 
NCT00612898
AVX-301
Yes
Avexa
Avexa
Not Provided
Study Director: Susan W Cox, Ph D Avexa Ltd
Principal Investigator: Michael Saag, MD UAB Center for AIDS Research
Avexa
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP