Completed
Delavirdine Mesylate, Zidovudine, Indinavir, and Lamivudine Combination for HIV-1 Infected Individuals
What is being tested
Indinavir sulfate
+ Delavirdine mesylate
+ Lamivudine
Drug
Who is being recruted
Blood-Borne Infections+11
+ Urogenital Diseases
+ Genital Diseases
Over 14 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 open-label pilot study, patients are randomized to 1of the following 4 arms for 24 weeks: Arm 1 (40 patients): DLV plus ZDV plus IDV. Arm 2 (40 patients): DLV plus IDV plus 3TC*. Arm 3 (40 patients): DLV plus ZDV plus IDV plus 3TC. Arm 4 (40 patients): ZDV plus IDV plus 3TC. Dose determined by body weight. Patients may opt to continue on study for 24 additional weeks at the discretion of the investigator.
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
160 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 14 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
CD4 count is above 50
HIV-1 RNA levels greater than 20,000
HIV-1 positive
Less than 1 month prior treatment with zidovudine
5 exclusion criteria prevent from participating
1 month or more prior zidovudine
Prior indinavir
Prior lamivudine
Prior 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