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

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. Identifier: NCT00002220
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
Information provided by:
NIH AIDS Clinical Trials Information Service

Brief Summary:
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 or disease Intervention/treatment Phase
HIV Infections Drug: Indinavir sulfate Drug: Efavirenz Drug: Levocarnitine Drug: Adefovir dipivoxil Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 120 participants
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

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MedlinePlus related topics: HIV/AIDS

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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:


Control group:

  • Prior efavirenz, adefovir dipivoxil, or other non-nucleoside reverse transcriptase inhibitors.


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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00002220

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. Identifier: NCT00002220     History of Changes
Obsolete Identifiers: NCT00002242
Other Study ID Numbers: 246N
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: June 1999

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

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Adefovir dipivoxil
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
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
Cytochrome P-450 CYP3A Inducers
HIV Protease Inhibitors
Protease Inhibitors
Anti-HIV Agents