Once a Day (QD) - Twice a Day (BID) Clinical Trial: Didanosine, Lamivudine and Efavirenz Versus Zidovudine, Lamivudine and Efavirenz in the Starting Treatment of HIV
HIV Infections
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring HIV infection, Highly active antiretroviral therapy, Treatment Naive
Eligibility Criteria
Inclusion Criteria: Chronic HIV infection with plasma RNA viral burden of HIV > 2,000 copies/ml obtained in the month prior to randomization. Ages 18 years or older. Women with childbearing potential should use an effective contraceptive method. The subjects should give their written informed consent. The subjects should provide the baseline laboratory values measured during the 4 weeks prior to the start of the study drugs, specified below: serum creatinine < 1.5 times the upper normal limit; total amylase < 1.4 times the upper normal limit; liver enzymes (AST, ALT) < 4 times the upper normal limit. Exclusion Criteria: Previous antiretroviral treatment. Suspected (acute) primary HIV infection starting less than six months before. Suspected or proven acute hepatitis in the 30 days prior to inclusion in the study. Subjects with chronic hepatitis are eligible provided their liver function enzymes < 4 times the upper normal limit. Previous therapy with agents with a significant potential of systemic myelosuppression, neurotoxicity, pancreatotoxicity, liver toxicity or cytotoxicity in the 3 months prior to the start of the study, or expected need for requiring therapy on inclusion, or therapy with methadone or ribavirin/interferons or treatment with neurotoxic drugs or drugs affecting CYP 3A4. Patients under methadone program Abuse of alcohol or drugs, sufficient, in the investigator's opinion, to prevent an adequate compliance with the study treatment or that could increase the risk of developing pancreatitis or toxic hepatitis. Untreatable diarrhea (> 6 loose stools/day for at least 7 consecutive days) within the 30 days prior to inclusion in the study. Pregnancy or nursing. History of bilateral peripheral neuropathy or signs and symptoms of bilateral peripheral neuropathy > Grade 2 on screening. Inability to tolerate oral drugs. Any other clinical condition or previous therapy that, in the investigator's opinion, leads the patient to be inadequate for the study or unable to comply with the dosage requirements.
Sites / Locations
- Hospital General de Área de Elda
- Hospital de Orihuela-Vega Baja, San Bartolomé-Orihuela
- Hospital General-Central de Asturias
- Hospital Son Dureta
- Hospital Son Llatzer
- Hospital General de Granollers
- Hospital de Terrassa
- Hospital Sant Llorenc de Viladecans
- Hospital General de Jerez de la Frontera11407
- Hospital Universitario Marqués de Valdecilla
- Hospital Sierrallana de Torrelavega
- Hospital Provincial Nuestra Señora de la Montaña-Complejo Hospitalario de Cáceres
- Hospital Comarcal de la Selva
- Hospital de Figueres
- Hospital de Palamós
- Hospital Donostia
- Hospital Arquitecto Marcide
- Hospital Príncipe de Asturias
- Hospital Severo Ochoa
- Hospital Costa del Sol
- Hospital Meixoeiro
- Hospital Xeral-Cíes de Vigo
- Hospital General Universitario Sant Joan de Reus
- Hospital de Basurto
- Hospital Universitario de San Juan de Alicante
- Hospital del Mar
- Hospital Santa Creu y Sant Pau
- Hospital General Vall D'Hebrón
- Hospital de Mollet
- Consorcio Sanitario de Mataró
- Hospital De Vic
- Hospital General Yagüe
- Hospital General de Castellón
- Hospital Provincial Reina Sofía de Córdoba
- Hospital Clínico Universitario San Cecilio
- Hospital Universitario Virgen de las Nieves
- Hospital General San Jorge
- Hospital Ciudad de Jaén
- Hospital Juan Canalejo
- Hospital de la Princesa
- Hospital Gregorio Marañón
- Hospital Ramón y Cajal
- Fundación Jiménez Díaz
- Hospital La Paz
- Hospital Carlos Haya
- Hospital Virgen de la Victoria
- Hospital Comarcal Axarquía de Vélez
- Hospital General Universitario de Murcia
- Hospital General Universitario Morales Meseguer
- Hospital de Covadonga-Central de Asturias
- Complejo Hospitalario de Pontevedra
- Hospital General de Segovia
- Hospital La Fe de Valencia
- Hospital Doctor Peset
- Hospital del Río Hortega
- Hospital Virgen de la Concha
- Hospital Miguel Servet