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

This study has been completed.
Sponsor:
Information provided by:
Clinical Trial Agency of HIV Study Group
ClinicalTrials.gov Identifier:
NCT00256828
First received: November 21, 2005
Last updated: October 15, 2007
Last verified: November 2005
  Purpose

The purpose of this study is to compare the antiviral activity of two treatment groups for HIV chronic infection: a QD regimen of didanosine, lamivudine and efavirenz versus a BID regimen of zidovudine, lamivudine and efavirenz. Both will be administered with food in the starting treatment of human immunodeficiency virus infection at Week 48.


Condition Intervention Phase
HIV Infections
Drug: didanosine + lamivudine + efavirenz
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Open Label, Clinical Trial Comparing a QD Regimen of Didanosine, Lamivudine and Efavirenz With a Standard BID Regimen of Zidovudine, Lamivudine and Efavirenz in the Starting Treatment of Human Immunodeficiency Virus Infection (GESIDA 39/03)

Resource links provided by NLM:


Further study details as provided by Clinical Trial Agency of HIV Study Group:

Primary Outcome Measures:
  • Percentage of patients with HIV-RNA levels < 50 c/ml (intent-to-treat [ITT])

Secondary Outcome Measures:
  • Percentage of patients with HIV-RNA level < 400 c/ml
  • Time to therapy failure
  • CD4 cell count increase from Baseline to Week 48 (w48)
  • Quality of life changes
  • Compliance to both treatment regimens
  • Description of adverse events

Estimated Enrollment: 360
Study Start Date: June 2004
Estimated Study Completion Date: November 2006
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00256828

  Hide Study Locations
Locations
Spain
Hospital General de Área de Elda
Elda, Alicante, Spain, 03600
Hospital de Orihuela-Vega Baja, San Bartolomé-Orihuela
Orihuela, Alicante, Spain, 03314
Hospital General-Central de Asturias
Oviedo, Asturias, Spain, 33006
Hospital Son Llatzer
Palma de Mallorca, Baleares, Spain, 07198
Hospital Son Dureta
Palma de Mallorca, Baleares, Spain, 07014
Hospital General de Granollers
Granollers, Barcelona, Spain, 08400
Hospital de Terrassa
Terrassa, Barcelona, Spain, 08227
Hospital Sant Llorenc de Viladecans
Viladecans,, Barcelona, Spain, 08840
Hospital General de Jerez de la Frontera11407
Jerez, Cadiz, Spain, 11407
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, Spain, 39008
Hospital Sierrallana de Torrelavega
Torrelavega, Cantabria, Spain, 39300
Hospital Provincial Nuestra Señora de la Montaña-Complejo Hospitalario de Cáceres
Caceres, Cáceres, Spain, 10003
Hospital Comarcal de la Selva
Blanes, Gerona, Spain, 17300
Hospital de Figueres
Figueras, Gerona, Spain, 17600
Hospital de Palamós
Palamos, Gerona, Spain, 17230
Hospital Donostia
San Sebastian, Guipuzcoa, Spain, 20014
Hospital Arquitecto Marcide
Ferrol, La Coruña, Spain, 15405
Hospital Príncipe de Asturias
Alcala de Henares, Madrid, Spain, 28880
Hospital Severo Ochoa
Leganes, Madrid, Spain, 28911
Hospital Costa del Sol
Marbella, Málaga, Spain, 29600
Hospital Meixoeiro
Vigo, Pontevedra, Spain, 36200
Hospital Xeral-Cíes de Vigo
Vigo, Pontevedra, Spain, 36204
Hospital General Universitario Sant Joan de Reus
Reus, Tarragona, Spain, 43201
Hospital de Basurto
Bilbao, Vizcaya, Spain, 48013
Hospital Universitario de San Juan de Alicante
Alicante, Spain, 03550
Hospital Santa Creu y Sant Pau
Barcelona, Spain, 08025
Hospital de Mollet
Barcelona, Spain, 08100
Hospital De Vic
Barcelona, Spain, 08500
Hospital General Vall D'Hebrón
Barcelona, Spain, 08035
Consorcio Sanitario de Mataró
Barcelona, Spain, 08304
Hospital del Mar
Barcelona, Spain, 08003
Hospital General Yagüe
Burgos, Spain, 09005
Hospital General de Castellón
Castellon, Spain, 12004
Hospital Provincial Reina Sofía de Córdoba
Cordoba, Spain, 14004
Hospital Clínico Universitario San Cecilio
Granada, Spain, 18012
Hospital Universitario Virgen de las Nieves
Granada, Spain, 18014
Hospital General San Jorge
Huesca, Spain, 22004
Hospital Ciudad de Jaén
Jaen, Spain, 23007
Hospital Juan Canalejo
La Coruña, Spain, 15006
Hospital Ramón y Cajal
Madrid, Spain, 28034
Hospital de la Princesa
Madrid, Spain, 28006
Fundación Jiménez Díaz
Madrid, Spain, 28040
Hospital Gregorio Marañón
Madrid, Spain, 28007
Hospital La Paz
Madrid, Spain, 28046
Hospital Carlos Haya
Malaga, Spain, 29010
Hospital Comarcal Axarquía de Vélez
Malaga, Spain, 29740
Hospital Virgen de la Victoria
Malaga, Spain, 29010
Hospital General Universitario de Murcia
Murcia, Spain, 30003
Hospital General Universitario Morales Meseguer
Murcia, Spain, 30008
Hospital de Covadonga-Central de Asturias
Oviedo, Spain, 33006
Complejo Hospitalario de Pontevedra
Pontevedra, Spain, 36001
Hospital General de Segovia
Segovia, Spain, 40002
Hospital Doctor Peset
Valencia, Spain, 46017
Hospital La Fe de Valencia
Valencia, Spain, 46009
Hospital del Río Hortega
Valladolid, Spain, 47010
Hospital Virgen de la Concha
Zamora, Spain, 49021
Hospital Miguel Servet
Zaragoza, Spain, 50009
Sponsors and Collaborators
Clinical Trial Agency of HIV Study Group
Investigators
Study Chair: Juan Berenguer Berenguer, MD Hospital Gregorio Marañón
  More Information

No publications provided by Clinical Trial Agency of HIV Study Group

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00256828     History of Changes
Other Study ID Numbers: GESIDA-3903
Study First Received: November 21, 2005
Last Updated: October 15, 2007
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Clinical Trial Agency of HIV Study Group:
HIV infection
Highly active antiretroviral therapy
Treatment Naive

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

ClinicalTrials.gov processed this record on July 23, 2014