A Study to Find the Best Dosing Schedule for Delavirdine, Zidovudine, and Indinavir in HIV-Positive Patients
Information source: NIH AIDS Clinical Trials Information Service
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: Indinavir sulfate (Drug); Delavirdine mesylate (Drug); Zidovudine (Drug)
Phase: N/A
Status: Completed
Sponsored by: Pharmacia and Upjohn
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.
Clinical Details
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 design: Treatment, Open Label, Pharmacokinetics Study
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.
Eligibility
Minimum age: 14 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
AIDS Healthcare Foundation, Los Angeles, California 90027, United States
UCSF AIDS Research Institute, San Francisco, California 94105, United States
Saint Luke's - Roosevelt Hosp Ctr, New York, New York 10019, United States
Anderson Clinical Research, Pittsburgh, Pennsylvania 15213, United States
Univ of Tennessee / Div of Infect Dis / Dept of Med, Memphis, Tennessee 38165, United States
Infectious Disease Physicians Inc, Annandale, Virginia 22203, United States
Additional Information
Last updated: June 23, 2005
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