Completed
Indinavir, Efavirenz, and Adefovir Dipivoxil Combination Therapy for HIV-Infected Patients
What is being tested
Indinavir sulfate
+ Efavirenz
+ Levocarnitine
Drug
Who is being recruted
Blood-Borne Infections+11
+ Urogenital Diseases
+ Genital Diseases
Over 16 Years
+8 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 3
Interventional
Summary
Principal SponsorMerck Sharp & Dohme LLC
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner
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.
Principal SponsorMerck Sharp & Dohme LLC
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
120 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 16 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsHIV Infections
Criteria
7 inclusion criteria required to participate
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
Serologically documented HIV infection
Must be naive to efavirenz, adefovir dipivoxil, and other NRTI's
Show More Criteria
1 exclusion criteria prevent from participating
Prior efavirenz, adefovir dipivoxil, or other non-nucleoside reverse transcriptase inhibitors
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 11 locations
LAC / USC Med Ctr / Infectious Diseases
Los Angeles, United StatesOpen LAC / USC Med Ctr / Infectious Diseases in Google MapsYale Univ / AIDS Clinical Trials Unit
New Haven, United StatesMed Ctr of Delaware
Wilmington, United StatesHawaii AIDS Clinical Trial Unit
Honolulu, United StatesCompleted11 Study Centers