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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002220
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: June 1999
  Purpose

The purpose of this study is to compare the effectiveness of giving indinavir plus efavirenz plus adefovir dipivoxil to patients who have failed treatment with nelfinavir and patients who have never taken a protease inhibitor (PI). Effectiveness is measured by the number of patients who have a viral load (level of HIV in the blood) below 400 copies/ml after 48 weeks of treatment.


Condition Intervention Phase
HIV Infections
Drug: Indinavir sulfate
Drug: Efavirenz
Drug: Levocarnitine
Drug: Adefovir dipivoxil
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Primary Purpose: Treatment
Official Title: Multi-Center, Open-Label Study of the Effect of Indinavir, Efavirenz, and Adefovir Dipivoxil Combination Therapy in Patients Who Have Failed Nelfinavir

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment: 120
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  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: NCT00002220

Locations
United States, California
LAC / USC Med Ctr / Infectious Diseases
Los Angeles, California, United States, 90033
United States, Connecticut
Yale Univ / AIDS Clinical Trials Unit
New Haven, Connecticut, United States, 06510
United States, Delaware
Med Ctr of Delaware
Wilmington, Delaware, United States, 19899
United States, Hawaii
Hawaii AIDS Clinical Trial Unit
Honolulu, Hawaii, United States, 96816
United States, Illinois
Rush Presbyterian Saint Lukes Med Ctr
Chicago, Illinois, United States, 606123832
United States, Maryland
Johns Hopkins Hosp
Baltimore, Maryland, United States, 212876220
United States, Massachusetts
Massachusetts Gen Hosp
Boston, Massachusetts, United States, 02114
United States, New York
Columbia Presbyterian Hosp
New York, New York, United States, 10032
AIDS TMT Unit / Univ Hosp
Stonybrook, New York, United States, 117948153
United States, Tennessee
Vanderbilt Clinic
Nashville, Tennessee, United States, 37212
United States, Texas
Oaklawn Physicians Group
Dallas, Texas, United States, 75219
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00002220     History of Changes
Obsolete Identifiers: NCT00002242
Other Study ID Numbers: 246N, 075-00
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Drug Resistance
Drug Therapy, Combination
Antiviral Agents
HIV Protease Inhibitors
Indinavir
RNA, Viral
Adenine
efavirenz

Additional relevant MeSH terms:
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
Indinavir
Adefovir dipivoxil
Adefovir
Efavirenz
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on October 19, 2014