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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.
Sponsored by: Clinical Trial Agency of HIV Study Group
Information provided by: Clinical Trial Agency of HIV Study Group
ClinicalTrials.gov Identifier: NCT00256828
  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 IV

MedlinePlus related topics: AIDS
Drug Information available for: Zidovudine Lamivudine Didanosine Efavirenz
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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)

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

  Show 59 Study Locations
Sponsors and Collaborators
Clinical Trial Agency of HIV Study Group
Investigators
Study Chair: Juan Berenguer Berenguer, MD Hospital Gregorio Marañón
  More Information

Publications indexed to this study:
Study ID Numbers: GESIDA-3903
Study First Received: November 21, 2005
Last Updated: October 15, 2007
ClinicalTrials.gov Identifier: NCT00256828  
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

Study placed in the following topic categories:
Virus Diseases
Efavirenz
Sexually Transmitted Diseases, Viral
Didanosine
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Lamivudine
Zidovudine
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Communicable Diseases
RNA Virus Infections
Anti-HIV Agents
Slow Virus Diseases
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Infection
Antiviral Agents
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on January 13, 2009