Completed
1592U89 and Selected HIV-1 Protease Inhibitors for Antiretroviral-Naive, HIV-1-Infected Patients
What is being tested
Indinavir sulfate
+ Ritonavir
+ Abacavir sulfate
Drug
Who is being recruted
Blood-Borne Infections+11
+ Urogenital Diseases
+ Genital Diseases
Over 16 Years
+22 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 2
Interventional
Summary
Principal SponsorGlaxo Wellcome
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner
In this Phase II, open-label study patients (16 per treatment group) are randomized to receive 1592U89 in combination with one of five protease inhibitors: indinavir, saquinavir, ritonavir, nelfinavir, or 141W94 for up to 48 weeks.
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.Design Details
80 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
5 inclusion criteria required to participate
CD4+ cell count >= 100 cells/mm3 within 14 days of study drug administration
HIV-1 RNA >= 5,000 copies/ml within 14 days of study drug administration
HIV-1 infection documented by a licensed HIV-1 antibody ELISA and confirmed by Western blot detection of HIV-1 antibody or a positive HIV-1 blood culture
No active or ongoing AIDS-defining opportunistic infection or disease
Show More Criteria
17 exclusion criteria prevent from participating
Agents with documented anti-HIV activity in vitro
Alcohol or illicit drug use that may interfere with patient compliance
Antioxidants
Antiretroviral therapy, including reverse transcriptase inhibitor and protease inhibitor therapy
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 8 locations
Yale U / New Haven Med Ctr / AIDS Clinical Trials Unit
New Haven, United StatesKansas City AIDS Research Consortium
Kansas City, United StatesNYU Med Ctr / Dept of Medicine / AIDS Clinical Trial
New York, United StatesCompleted8 Study Centers