Search / Trial NCT00002234

Safety and Effectiveness of Giving an Anti-HIV Drug Combination of Adefovir Dipivoxil Plus Didanosine Plus Efavirenz Plus Lamivudine Once Daily to HIV-Infected Patients

Launched by GILEAD SCIENCES · Aug 30, 2001

Trial Information

Current as of December 26, 2024

Completed

Keywords

Drug Therapy, Combination Reverse Transcriptase Inhibitors Anti Hiv Agents

ClinConnect Summary

Patients receive a treatment regimen of adefovir dipivoxil, didanosine, efavirenz, and lamivudine for 48 weeks. During the study, patients are evaluated for changes from baseline in plasma HIV-1 RNA and lymphocyte subsets and for the development of adverse experiences and laboratory toxicities. At Weeks 8, 12, 24, and 48, patients are assessed for adherence to study treatment with a questionnaire. Patients who experience virologic failure are discontinued from the study. Patients who experience treatment intolerance may have their antiretroviral treatment regimens changed. After Week 48, pa...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria
  • You may be eligible for this study if you:
  • Are HIV-positive.
  • Are at least 13 years old (need consent of parent or guardian if under 18).
  • Have an HIV count of 5,000 copies/ml or more within 30 days prior to study entry.
  • Have a CD4+ count of 50 cells/mm3 or more.
  • Exclusion Criteria
  • You will not be eligible for this study if you:
  • Are diagnosed with hepatitis within 30 days prior to study entry.
  • Have certain serious medical conditions, including an AIDS-defining clinical condition.
  • Received chemotherapy or radiation therapy within 30 days of study entry.
  • Have taken any nucleoside reverse transcriptase inhibitors (NRTIs) for more than 2 weeks.
  • Have ever taken 3TC.
  • Have ever taken any non-nucleoside reverse transcriptase inhibitors (NNRTIs).
  • Have taken medications that affect your immune system within 30 days prior to study entry.
  • Have received a vaccine within 30 days prior to study entry.
  • Are enrolled in another anti-HIV drug study while participating in this study.
  • Abuse alcohol or drugs.
  • Are pregnant or breast-feeding.

About Gilead Sciences

Gilead Sciences is a leading biopharmaceutical company focused on the discovery, development, and commercialization of innovative medicines to address unmet medical needs. With a strong emphasis on antiviral therapies, particularly for HIV, hepatitis B, hepatitis C, and influenza, Gilead leverages advanced research and development capabilities to drive breakthroughs in treatment and care. The company is committed to improving patient outcomes through rigorous clinical trials, fostering collaborations with healthcare professionals, and engaging in partnerships to enhance global health. Gilead's dedication to scientific excellence and patient-centric approaches positions it at the forefront of the biopharmaceutical industry.

Locations

Atlanta, Georgia, United States

Providence, Rhode Island, United States

Hampton, Virginia, United States

Beverly Hills, California, United States

Denver, Colorado, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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