Completed
Combination Drug Therapy for HIV-1-Positive Patients
What is being tested
Indinavir sulfate
+ Delavirdine mesylate
+ Lamivudine
Drug
Who is being recruted
Blood-Borne Infections+11
+ Urogenital Diseases
+ Genital Diseases
Over 18 Years
+9 Eligibility Criteria
How is the trial designed
Treatment Study
Interventional
Summary
Principal SponsorPharmacia and Upjohn
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner
In this multicenter, open-label study, 45 HIV-1-positive patients receive either combination drug therapy with delavirdine (DLV), zidovudine (ZDV), and indinavir (IDV) or combination drug therapy with ZDV, lamivudine (3TC), and IDV. NOTE: Patients are treated for 24 weeks and may opt to continue on study for 24 additional weeks, if HIV-1 RNA is less than 5,000 copies/ml or at the investigator's discretion.
Principal SponsorPharmacia and Upjohn
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
45 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
4 inclusion criteria required to participate
Allowed: Less than 1 month prior treatment with zidovudine
Patients must have: CD4 count above 50
Patients must have: HIV-1 RNA greater than 20,000
Patients must have: HIV-1 positive
5 exclusion criteria prevent from participating
Excluded: Prior 3TC, protease inhibitors, or non-nucleoside reverse transcriptase inhibitors
Excluded: Prior ZDV of greater than 1 month total duration
Excluded: Prior treatment with lamivudine
Excluded: Prior treatment with non-nucleoside reverse transcriptase inhibitors
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 1 location
CompletedOne Study Center