Suspended
Indinavir and Ritonavir with NRTIs for Early HIV-1 Treatment
What is being tested
Indinavir sulfate
+ Ritonavir
Drug
Who is being recruted
Blood-Borne Infections+11
+ Urogenital Diseases
+ Genital Diseases
Over 18 Years
+8 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 2
Interventional
Summary
Principal SponsorMerck Sharp & Dohme LLC
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner
Patients receive indinavir bid plus ritonavir bid, plus 2 NRTIs bid (2 new NRTIs or 1 new NRTI and 1 NRTI without evidence of resistance). CD4 cell counts and plasma viral RNA are measured every 4 weeks for the duration of the study. Physical examination and laboratory tests of blood and urine are performed every 4 weeks for the duration of the study. Chest x-ray and 12-lead ECG are done prestudy.
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
100 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 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
8 inclusion criteria required to participate
Are 18 years of age or older
Are HIV-positive
Are naive to at least one of the selected NRTIs
Have a CD4 cell count of at least 50 cells/mm3
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 40 locations
Ocean View Internal Medicine
Long Beach, United StatesBisher Akil
Los Angeles, United StatesTower Infectious Diseases / Med Associates Inc
Los Angeles, United StatesSuspended40 Study Centers