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

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Indinavir sulfate
Efavirenz
Levocarnitine
Adefovir dipivoxil
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Drug Resistance, Drug Therapy, Combination, Antiviral Agents, HIV Protease Inhibitors, Indinavir, RNA, Viral, Adenine, efavirenz

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • LAC / USC Med Ctr / Infectious Diseases
  • Yale Univ / AIDS Clinical Trials Unit
  • Med Ctr of Delaware
  • Hawaii AIDS Clinical Trial Unit
  • Rush Presbyterian Saint Lukes Med Ctr
  • Johns Hopkins Hosp
  • Massachusetts Gen Hosp
  • Columbia Presbyterian Hosp
  • AIDS TMT Unit / Univ Hosp
  • Vanderbilt Clinic
  • Oaklawn Physicians Group

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00002220
Brief Title
Indinavir Plus Efavirenz Plus Adefovir Dipivoxil in HIV-Infected Patients Who Have Not Had Success With Nelfinavir
Official Title
Multi-Center, Open-Label Study of the Effect of Indinavir, Efavirenz, and Adefovir Dipivoxil Combination Therapy in Patients Who Have Failed Nelfinavir
Study Type
Interventional

2. Study Status

Record Verification Date
June 1999
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Merck Sharp & Dohme LLC

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Drug Resistance, Drug Therapy, Combination, Antiviral Agents, HIV Protease Inhibitors, Indinavir, RNA, Viral, Adenine, efavirenz

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Enrollment
120 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Indinavir sulfate
Intervention Type
Drug
Intervention Name(s)
Efavirenz
Intervention Type
Drug
Intervention Name(s)
Levocarnitine
Intervention Type
Drug
Intervention Name(s)
Adefovir dipivoxil

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
LAC / USC Med Ctr / Infectious Diseases
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Yale Univ / AIDS Clinical Trials Unit
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Med Ctr of Delaware
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19899
Country
United States
Facility Name
Hawaii AIDS Clinical Trial Unit
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96816
Country
United States
Facility Name
Rush Presbyterian Saint Lukes Med Ctr
City
Chicago
State/Province
Illinois
ZIP/Postal Code
606123832
Country
United States
Facility Name
Johns Hopkins Hosp
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
212876220
Country
United States
Facility Name
Massachusetts Gen Hosp
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Columbia Presbyterian Hosp
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
AIDS TMT Unit / Univ Hosp
City
Stonybrook
State/Province
New York
ZIP/Postal Code
117948153
Country
United States
Facility Name
Vanderbilt Clinic
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Facility Name
Oaklawn Physicians Group
City
Dallas
State/Province
Texas
ZIP/Postal Code
75219
Country
United States

12. IPD Sharing Statement

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

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