Search / Trial NCT00002220

Indinavir Plus Efavirenz Plus Adefovir Dipivoxil in HIV-Infected Patients Who Have Not Had Success With Nelfinavir

Launched by MERCK SHARP & DOHME LLC · Aug 30, 2001

Trial Information

Current as of December 26, 2024

Completed

Keywords

Drug Resistance Drug Therapy, Combination Antiviral Agents Hiv Protease Inhibitors Indinavir Rna, Viral Adenine Efavirenz

ClinConnect Summary

In this open-label, nonrandomized study, 120 HIV-infected patients are stratified into two groups: failed nelfinavir vs protease inhibitor-naive. All patients receive indinavir plus efavirenz plus adefovir dipivoxil plus and L-carnitine, orally. Plasma vRNA is measured every 4 weeks until Week 16, then every 8 weeks for the remainder of the 48-week study.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria
  • Patients must have:
  • Serologically documented HIV infection.
  • Baseline CD4 count greater than or equal to 50 cells and vRNA greater than or equal to 10,000 copies/ml.
  • Parental consent for patients under 18.
  • Nelfinavir-Failure Group:
  • Must have protease inhibitor experience solely with nelfinavir and be considered drug-adherent.
  • Must be candidate for changing therapy because of virologic failure and be receiving nelfinavir at entry (at least 16 weeks of nelfinavir plus NRTI therapy with at least a 10-fold decline in vRNA due to nelfinavir therapy and a subsequent increase toward the patient's baseline vRNA of at least 10-fold).
  • Control Group:
  • Must have received any combination of currently licensed nucleoside reverse transcriptase inhibitors for at least 16 weeks.
  • Must be naive to efavirenz, adefovir dipivoxil, and other NRTI's.
  • Exclusion Criteria
  • Prior Medication:
  • Excluded:
  • Control group:
  • Prior efavirenz, adefovir dipivoxil, or other non-nucleoside reverse transcriptase inhibitors.
  • Required:
  • Nelfinavir-failure patients:
  • At least 16 weeks of nelfinavir.
  • Control group:
  • At least 16 weeks of any combination of currently licensed nucleoside reverse transcriptase inhibitors.

About Merck Sharp & Dohme Llc

Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., is a leading global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines and vaccines that address unmet medical needs. With a strong focus on research and development, Merck Sharp & Dohme leverages advanced science and technology to enhance patient outcomes across various therapeutic areas, including oncology, infectious diseases, and cardiovascular health. Committed to ethical practices and regulatory compliance, the company actively engages in clinical trials to advance medical knowledge and improve health care for patients worldwide.

Locations

Baltimore, Maryland, United States

Boston, Massachusetts, United States

Los Angeles, California, United States

New Haven, Connecticut, United States

Wilmington, Delaware, United States

Honolulu, Hawaii, United States

Chicago, Illinois, United States

New York, New York, United States

Stonybrook, New York, United States

Nashville, Tennessee, United States

Dallas, Texas, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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