Study of the Efficacy and Safety of Apricitabine, a New NRTI, to Treat Drug-resistant HIV Infection
- Registration Number
- NCT00612898
- Lead Sponsor
- Avexa
- 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.
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 239
- HIV-1 positive with M184V/I mutation in reverse transcriptase;
- 18 years of age or older;
- Currently taking lamivudine (3TC) or emtricitabine (FTC)
- Female patients who are pregnant or breastfeeding;
- Current hepatitis B virus (HBV) infection;
- Current treatment for hepatitis C virus infection;
- Renal function not adequate
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 lamivudine 150mg BID lamivudine plus optimised background 1 apricitabine 800mg BID apricitabine plus optimised background
- Primary Outcome Measures
Name Time Method Proportion of patients with plasma HIV-1 RNA <50 copies/mL at W24 week 24
- Secondary Outcome Measures
Name Time Method Proportion of patients with plasma HIV-1 RNA <50 copies/mL at W48 week 48 Time to loss of virological response (TLOVR analysis; FDA algorithm) at W12, W24 and W48 (<50 copies/mL) week 12, 24, and 48
Trial Locations
- Locations (100)
UAB, 845 19th St South, South Beville Biomedical Research Building
🇺🇸Birmingham, Alabama, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Southwest Center for HIV/AIDS
🇺🇸Phoenix, Arizona, United States
Living Hope Clinical Foundation, Inc
🇺🇸Long Beach, California, United States
Kaiser Permanente Medical Center
🇺🇸San Francisco, California, United States
AIDS Research Alliance
🇺🇸West Hollywood, California, United States
Denver Health & Hospital Authority
🇺🇸Denver, Colorado, United States
Georgetown University
🇺🇸Washington, District of Columbia, United States
George Washington University
🇺🇸Washington, District of Columbia, United States
Gary Richmond, MD
🇺🇸Fort Lauderdale, Florida, United States
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