Back to resultsA Study to Find the Best Dosing Schedule for Delavirdine, Zidovudine, and Indinavir in HIV-Positive Patients
Primary Purpose
HIV Infections
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Indinavir sulfate
Delavirdine mesylate
Zidovudine
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Drug Therapy, Combination, Zidovudine, Drug Administration Schedule, HIV Protease Inhibitors, CD4 Lymphocyte Count, Indinavir, Delavirdine, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load
Eligibility Criteria
Inclusion Criteria You may be eligible for this study if you: Are HIV-positive. Have a viral load (level of HIV in the blood) of at least 20,000 copies/ml. Have a CD4 cell count of at least 50 cells/mm3. Are at least 14 years old (consent of parent or guardian is required if under 18). Exclusion Criteria You will not be eligible for this study if you: Have ever taken an anti-HIV drug other than ZDV. Have taken ZDV for more than 1 month.
Sites / Locations
- AIDS Healthcare Foundation
- UCSF AIDS Research Institute
- Saint Luke's - Roosevelt Hosp Ctr
- Anderson Clinical Research
- Univ of Tennessee / Div of Infect Dis / Dept of Med
- Infectious Disease Physicians Inc
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00002236
Brief Title
A Study to Find the Best Dosing Schedule for Delavirdine, Zidovudine, and Indinavir in HIV-Positive Patients
Official Title
An Open-Label, Parallel Group, Pilot Study of Safety, Tolerance, Pharmacokinetics and Pharmacodynamics of BID and TID Regimens of Delavirdine Mesylate, Zidovudine, and Indinavir Sulfate in HIV-1 Infected Individuals
Study Type
Interventional
2. Study Status
Record Verification Date
April 2000
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 whether it is better to take delavirdine (DLV) plus indinavir (IDV) plus zidovudine (ZDV) twice a day or three times a day.
Detailed Description
Patients are divided into 2 treatment groups; the groups are balanced with respect to viral load. Group A receives ZDV, DLV, and IDV 3 times daily. Group B receives ZDV, DLV, and IDV 2 times daily. Patients are evaluated for changes from baseline in viral load and CD4 cell count.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Drug Therapy, Combination, Zidovudine, Drug Administration Schedule, HIV Protease Inhibitors, CD4 Lymphocyte Count, Indinavir, Delavirdine, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Masking
None (Open Label)
Enrollment
32 (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)
Zidovudine
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
You may be eligible for this study if you:
Are HIV-positive.
Have a viral load (level of HIV in the blood) of at least 20,000 copies/ml.
Have a CD4 cell count of at least 50 cells/mm3.
Are at least 14 years old (consent of parent or guardian is required if under 18).
Exclusion Criteria
You will not be eligible for this study if you:
Have ever taken an anti-HIV drug other than ZDV.
Have taken ZDV for more than 1 month.
Facility Information:
Facility Name
AIDS Healthcare Foundation
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
UCSF AIDS Research Institute
City
San Francisco
State/Province
California
ZIP/Postal Code
94105
Country
United States
Facility Name
Saint Luke's - Roosevelt Hosp Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
Facility Name
Anderson Clinical Research
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Univ of Tennessee / Div of Infect Dis / Dept of Med
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38165
Country
United States
Facility Name
Infectious Disease Physicians Inc
City
Annandale
State/Province
Virginia
ZIP/Postal Code
22203
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study to Find the Best Dosing Schedule for Delavirdine, Zidovudine, and Indinavir in HIV-Positive Patients
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