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

Sponsored by:	Merck
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00002220

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 III

MedlinePlus related topics: AIDS

Drug Information available for: Indinavir Indinavir Sulfate Nelfinavir Nelfinavir Mesylate Efavirenz Adefovir dipivoxil Adefovir Carnitine Adenine

U.S. FDA Resources

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

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

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

More Information

Study ID Numbers:	246N, 075-00
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00002220
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

Study placed in the following topic categories:

Efavirenz
Sexually Transmitted Diseases, Viral
Indinavir
Acquired Immunodeficiency Syndrome
Immunologic Deficiency Syndromes
Virus Diseases
HIV Infections

Sexually Transmitted Diseases
Adefovir dipivoxil
Nelfinavir
Retroviridae Infections
Adefovir
Carnitine

Additional relevant MeSH terms:

Anti-Infective Agents
HIV Protease Inhibitors
RNA Virus Infections
Anti-HIV Agents
Slow Virus Diseases
Vitamin B Complex
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Growth Substances
Physiological Effects of Drugs
Enzyme Inhibitors

Infection
Antiviral Agents
Pharmacologic Actions
Protease Inhibitors
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Vitamins
Lentivirus Infections
Micronutrients
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on January 14, 2009