- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002401
A Study of Delavirdine Used Together With Other Anti-HIV Drugs in HIV-Infected Patients
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New Jersey
-
Peapack, New Jersey, United States, 07977
- Pharmacia & Upjohn
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
Collaborators and Investigators
Sponsor
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- HIV Infections
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Reverse Transcriptase Inhibitors
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Antimetabolites
- Protease Inhibitors
- HIV Protease Inhibitors
- Viral Protease Inhibitors
- Lamivudine
- Zidovudine
- Indinavir
- Delavirdine
Other Study ID Numbers
- 228F
- 0074
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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