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
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00256828 |
Recruitment Status
:
Completed
First Posted
: November 22, 2005
Last Update Posted
: October 16, 2007
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Drug: didanosine + lamivudine + efavirenz | Phase 4 |

Study Type : | Interventional (Clinical Trial) |
Enrollment : | 360 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (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) |
Study Start Date : | June 2004 |
Study Completion Date : | November 2006 |

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

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00256828

Study Chair: | Juan Berenguer Berenguer, MD | Hospital Gregorio Marañón |
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 |
First Posted: | November 22, 2005 Key Record Dates |
Last Update Posted: | October 16, 2007 |
Last Verified: | November 2005 |
Keywords provided by Clinical Trial Agency of HIV Study Group:
HIV infection Highly active antiretroviral therapy Treatment Naive |
Additional relevant MeSH terms:
Infection HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Lamivudine Zidovudine Efavirenz |
Didanosine Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Anti-HIV Agents Antimetabolites Cytochrome P-450 CYP2C9 Inhibitors Cytochrome P-450 Enzyme Inhibitors Cytochrome P-450 CYP2C19 Inhibitors Cytochrome P-450 CYP2B6 Inducers Cytochrome P-450 Enzyme Inducers |