Completed
Comparison of Four-Drug (141W94, 1592U89, Combivir) vs. Three-Drug (Nelfinavir, Combivir) Regimen in Antiretroviral-Naive HIV-Infected Patients
Study Aim
This study compares the effectiveness of a four-drug regimen (141W94, 1592U89, Combivir) versus a three-drug regimen (Nelfinavir, Combivir) in treating HIV-infected individuals who have not previously received antiretroviral therapy.
What is being tested
Lamivudine/Zidovudine
+ Abacavir sulfate
+ Amprenavir
Drug
Who is being recruted
Blood-Borne Infections+11
+ Urogenital Diseases
+ Genital Diseases
Over 18 Years
+10 Eligibility Criteria
How is the trial designed
Treatment Study
Interventional
Summary
Principal SponsorGlaxo Wellcome
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner
In this open-label study antiretroviral-naive patients are randomized to one of two drug regimens: Arm I: 141W94 (amprenavir), 1592U89 (abacavir), and Combivir (3TC/AZT tablet). Arm II: Nelfinavir and Combivir.
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
Ability to comply with dosing schedule and protocol evaluations
Allowed: 3TC or any protease inhibitor, if < 1 week of therapy
Allowed: Other nucleoside analogs, if < 4 weeks of therapy
CD4 count > 50
Show More Criteria
4 exclusion criteria prevent from participating
Enrollment in any other investigational drug protocol
Patients with any of the following symptoms or conditions are excluded: Active AIDS (not including CD4 count < 200)
Patients with any of the following symptoms or conditions are excluded: Malabsorption syndrome affecting drug absorption
Prior Medication: Excluded: 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 1 location
CompletedOne Study Center