Back to resultsA Study of Delavirdine Used Together With Other Anti-HIV Drugs in HIV-Infected Patients
Primary Purpose
HIV Infections
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Indinavir sulfate
Delavirdine mesylate
Lamivudine
Zidovudine
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring HIV-1, Zidovudine, HIV Protease Inhibitors, Lamivudine, Indinavir, RNA, Viral, Delavirdine, Reverse Transcriptase Inhibitors, Viral Load
Eligibility Criteria
Inclusion Criteria Prior Medication: Allowed: Less than 1 month prior treatment with zidovudine. Exclusion Criteria Prior Medication: Excluded: Prior indinavir. Prior lamivudine. Prior protease inhibitors. Prior non-nucleoside reverse transcriptase inhibitors. 1 month or more prior zidovudine. 1. HIV-1 positive. CD4 coun tis above 50. HIV-1 RNA levels greater than 20,000.
Sites / Locations
- Pharmacia & Upjohn
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00002401
Brief Title
A Study of Delavirdine Used Together With Other Anti-HIV Drugs in HIV-Infected Patients
Official Title
An Open-Label Randomized Study of Delavirdine Mesylate (DLV, Rescriptor) in Triple and Quadruple Combinations With Zidovudine (ZDV), Indinavir (IDV), and Lamivudine (3TC) in HIV-1 Infected Individuals
Study Type
Interventional
2. Study Status
Record Verification Date
January 1999
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Pharmacia and Upjohn
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to see if it is safe and effective to give delavirdine (DLV) in combination with two or three other drugs to HIV-infected patients. The drugs to be used in combination with DLV are zidovudine (ZDV), indinavir (IDV), and lamivudine (3TC).
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV-1, Zidovudine, HIV Protease Inhibitors, Lamivudine, Indinavir, RNA, Viral, Delavirdine, Reverse Transcriptase Inhibitors, Viral Load
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Enrollment
160 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Indinavir sulfate
Intervention Type
Drug
Intervention Name(s)
Delavirdine mesylate
Intervention Type
Drug
Intervention Name(s)
Lamivudine
Intervention Type
Drug
Intervention Name(s)
Zidovudine
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
Prior Medication:
Allowed:
Less than 1 month prior treatment with zidovudine.
Exclusion Criteria
Prior Medication:
Excluded:
Prior indinavir.
Prior lamivudine.
Prior protease inhibitors.
Prior non-nucleoside reverse transcriptase inhibitors.
1 month or more prior zidovudine.
1. HIV-1 positive.
CD4 coun tis above 50.
HIV-1 RNA levels greater than 20,000.
Facility Information:
Facility Name
Pharmacia & Upjohn
City
Peapack
State/Province
New Jersey
ZIP/Postal Code
07977
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study of Delavirdine Used Together With Other Anti-HIV Drugs in HIV-Infected Patients
We'll reach out to this number within 24 hrs