Completed
Epivir Dosage Comparison in HIV-1 Treatment
What is being tested
Indinavir sulfate
+ Nelfinavir mesylate
+ Lamivudine
Drug
Who is being recruted
Blood-Borne Infections+11
+ Urogenital Diseases
+ Genital Diseases
Over 18 Years
+12 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 2
Interventional
Study Start: June 1999
Summary
Principal SponsorGlaxo Wellcome
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner
Study start date: June 1, 1999
Actual date on which the first participant was enrolled.Patients are randomized to 1 of 2 groups. Group 1 receives 3TC qd plus d4T plus either IDV or NFV. Group 2 receives 3TC bid plus d4T plus either IDV or NFV. Patients are evaluated for drug tolerance, medication adherence, and genotypic and phenotypic resistance.
Principal SponsorGlaxo Wellcome
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.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 18 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
6 inclusion criteria required to participate
Agree to abstain from sex or use effective methods of birth control during the study
Are HIV-positive
Are at least 18 years old
Are currently taking an anti-HIV drug regimen that includes 3TC plus d4T plus either IDV or NFV for at least 6 months prior to study entry. (Note: This must be their first anti-HIV drug regimen.)
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6 exclusion criteria prevent from participating
Are allergic to any of the study drugs
Are pregnant or breast-feeding
Are unable to take medication by mouth for any reason
Have a history of an AIDS-defining illness or certain other medical conditions
Show More Criteria
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 12 locations
Palo Alto Veterans Affairs Health Care System
Palo Alto, United StatesDupont Circle Physicians Group
Washington D.C., United StatesIDC Research Initiative
Altamonte Springs, United StatesCompleted12 Study Centers