Back to resultsA Study of Two Anti-HIV Drug Combinations 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, Drug Therapy, Combination, Zidovudine, HIV Protease Inhibitors, Lamivudine, Indinavir, RNA, Viral, Delavirdine, Reverse Transcriptase Inhibitors
Eligibility Criteria
Inclusion Criteria Patients must have: HIV-1 positive. CD4 count above 50. HIV-1 RNA greater than 20,000. Prior Medication: Allowed: Less than 1 month prior treatment with zidovudine. Exclusion Criteria Prior Medication: Excluded: Prior 3TC, protease inhibitors, or non-nucleoside reverse transcriptase inhibitors. Prior ZDV of greater than 1 month total duration. Prior Treatment: Excluded: Lamivudine. Protease inhibitors. Non-nucleoside reverse transcriptase inhibitors.
Sites / Locations
- Pharmacia & Upjohn
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00002400
Brief Title
A Study of Two Anti-HIV Drug Combinations in HIV-Infected Patients
Official Title
An Open-Label Randomized Study of Delavirdine Mesylate (Rescriptor) in Combination With Zidovudine (Retrovir) and Two Doses of Indinavir (Crixivan) Versus Zidovudine, Lamivudine (Epivir), and Indinavir 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 compare the safety and effectiveness of giving HIV-infected patients delavirdine (DLV) plus zidovudine (ZDV) plus 2 doses of indinavir (IDV) or ZDV plus IDV plus lamivudine (3TC). This study also examines how the body processes DLV when it is given in combination with other drugs.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV-1, Drug Therapy, Combination, Zidovudine, HIV Protease Inhibitors, Lamivudine, Indinavir, RNA, Viral, Delavirdine, Reverse Transcriptase Inhibitors
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Enrollment
45 (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
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
Patients must have:
HIV-1 positive.
CD4 count above 50.
HIV-1 RNA greater than 20,000.
Prior Medication:
Allowed:
Less than 1 month prior treatment with zidovudine.
Exclusion Criteria
Prior Medication:
Excluded:
Prior 3TC, protease inhibitors, or non-nucleoside reverse transcriptase inhibitors.
Prior ZDV of greater than 1 month total duration.
Prior Treatment:
Excluded:
Lamivudine.
Protease inhibitors.
Non-nucleoside reverse transcriptase inhibitors.
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 Two Anti-HIV Drug Combinations in HIV-Infected Patients
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