Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT00002220
NCT00002220CompletedPhase 3

Multi-Center, Open-Label Study of the Effect of Indinavir, Efavirenz, and Adefovir Dipivoxil Combination Therapy in Patients Who Have Failed Nelfinavir

Merck Sharp & Dohme LLC21 sites in 1 country120 target enrollmentStarted: August 31, 2001Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
120
Locations
21
Study OverviewStudy DesignEligibility CriteriaInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Primary Purpose
Treatment

Eligibility Criteria

Ages
16 Years to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Investigators

Sponsor Class
Industry

Study Sites (21)

Loading locations...

Similar Trials

Unknown
Phase 2
The Safety and Effectiveness of Indinavir Plus Ritonavir Plus Two NRTIs in HIV-Infected Patients Who Need Early Intervention TreatmentHIV Infections
NCT00005118Merck Sharp & Dohme LLC100
Completed
Not Applicable
A Study to Find the Best Dosing Schedule for Delavirdine, Zidovudine, and Indinavir in HIV-Positive PatientsHIV Infections
NCT00002236Pharmacia and Upjohn32
Completed
Phase 3
A Comparison of Two Dose Levels of Indinavir Combined With Two Nucleoside Analogue Reverse Transcriptase Inhibitors (NRTIs) in HIV-Infected PatientsHIV Infections
NCT00002406Merck Sharp & Dohme LLC350
Unknown
Phase 4
Treatment With Nelfinavir or Efavirenz of HIV-Infected Patients Who Have Never Received Anti-HIV DrugsHIV Infections
NCT00005000Agouron Pharmaceuticals200
Completed
Phase 2
A Study of Indinavir Plus Ritonavir Plus Two NRTIs vs. Nelfinavir Plus Two NRTIs in HIV Positive Patients (0639-112)(COMPLETED)HIV Infections
NCT00541463Merck Sharp & Dohme LLC330
Indinavir Plus Efavirenz Plus Adefovir... | Clinical Trial