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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.
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

  Show 57 Study Locations
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
Communicable Diseases
HIV Infections
Infection
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Didanosine
Efavirenz
Lamivudine
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antimetabolites
Antiviral Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014