Elvucitabine/Efavirenz/Tenofovir Versus Lamivudine/Efavirenz/Tenofovir in Human Immunodeficiency Virus (HIV)-1 Infected, Treatment-naive Participants
HIV Infections

About this trial
This is an interventional treatment trial for HIV Infections focused on measuring HIV-1 treatment naive
Eligibility Criteria
Inclusion Criteria: A participant must meet the following criteria at Screening to be enrolled in this study: Are male or female. Sexually active men with partners of childbearing potential must agree to use an acceptable form of contraception as determined by the investigator (for example, oral contraceptives, double-barrier methods, hormonal injectable or implanted contraceptives, tubal ligation, or vasectomy) during participation in the study. Female participants cannot be pregnant or lactating/breast-feeding and must be surgically sterile, postmenopausal as defined later, or practicing an effective method of birth control as determined by the investigator (for example oral contraceptives, double-barrier methods, hormonal injectable or implanted contraceptives, tubal ligation, or partner with vasectomy). A woman may be considered postmenopausal if she is at least 50 years or older, has a history of no menses for at least 12 months, and has a follicle-stimulating hormone (FSH) level over the upper limit of normal for reproductive aged women. Are 18 through 65 years old Have documented HIV-1 infection by written prior history and clinically stable with no AIDS-defining events in the 3 months prior to Screening Have plasma HIV-1 RNA levels greater than or equal to 5000 copies/mL at Screening Are HIV-1 strain sensitive to elvucitabine, lamivudine, or emtricitabine as demonstrated by the absence of the M184V, M184I, and D237E mutations by TRUGENE HIV-1 Genotyping Kit Are HIV-1 strain genotypically sensitive to efavirenz (negative for K103 and Y188L mutations) and tenofovir (negative for K65R mutation) by TRUGENE HIV-1 Genotyping Kit Have a CD4 count greater than or equal to 200 cells/mL and less than 500 cells/mL Have acceptable hematologic and chemistry parameters, including the following: Hemoglobin (Hgb) greater than or equal to 11 grams (g)/deciliter (dL) Absolute neutrophil count greater than or equal to 2000 cells/mm^3 Platelets greater than or equal to 125 000/mm^3 Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than or equal to 1.5 times the upper limit of normal Total bilirubin less than or equal to 1.5 times the upper limit of normal Creatinine within normal range Are capable of understanding and has signed the informed consent document Are able and willing to comply with protocol requirements Exclusion Criteria: Participants meeting any of the following criteria at Screening will be excluded from the study: Are hepatitis B surface antigen positive, and/or hepatitis B virus (HBV) deoxyribonucleic acid (DNA) positive Have previous therapy with agents with significant systemic myelosuppressive or cytotoxic potential within the 3 months prior to Screening or the expected need for such therapy during the study Have previous use or need for bone marrow colony-stimulating factors such as Epogen, Procrit, or Neupogen Have had previous antiretroviral therapy Have evidence or history of cirrhosis Have recent (within 3 months of Screening) history of alcohol abuse, physical dependence to any opioid, cocaine, lysergic acid diethylamide (LSD) or amphetamines, or history of drug addiction within the last 12 months Have inability to tolerate oral medication Are pregnant or breast-feeding if female Have any clinical condition or prior therapy that, in the investigator's opinion, would make the participant unsuitable for the study or unable to comply with the dosing requirements Have received treatment with any other investigational drug within 30 days prior to Screening Have current active mental illness or a history of significant mental illness (for example, severe depression, schizophrenia, history of suicidal ideations, or suicide attempts)
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Elvucitabine, Efavirenz, Tenofovir
Lamivudine, Efavirenz, Tenofovir
Elvucitabine (blinded) 10 milligrams (mg)/day in combination with open-label efavirenz 600 mg daily and open-label tenofovir 300 mg daily, all administered orally, over 12 weeks. Eligible participants continued with an additional 84 weeks of open-label treatment (through Week 96). Participants who experienced at least a 2 log10 decrease in HIV-1 RNA from Baseline or who had an HIV-1 RNA level of less than 400 copies/ mL at Week 10 and had not experienced any Grade 3 or 4 hematological toxicity as of the Week 10 measurement were considered eligible for an additional 84 weeks of open-label treatment after Week 12.
Lamivudine (blinded) 300 mg daily in combination with open-label efavirenz 600 mg daily and open-label tenofovir 300 mg daily, all administered orally, over 12 weeks. Eligible participants continued with an additional 84 weeks of open-label treatment (through Week 96). Participants who experienced at least a 2 log10 decrease in HIV-1 RNA from Baseline or who had an HIV-1 RNA level of less than 400 copies/mL at Week 10 and had not experienced any Grade 3 or 4 hematological toxicity as of the Week 10 measurement were considered eligible for an additional 84 weeks of open-label treatment after Week 12.