A Study of Two Anti-HIV Drug Combinations in HIV-Infected Patients
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...
Brief Summary
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”
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.
- Study Type: Interventional
- Study Design: Endpoint Classification: Safety Study, Primary Purpose: Treatment
Detailed Clinical Trial 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.
Intervention(s) in this Clinical Trial
- Drug: Indinavir sulfate
- Drug: Delavirdine mesylate
- Drug: Lamivudine
- Drug: Zidovudine
Criteria for Participation in this Clinical Trial
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.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Pharmacia and Upjohn Industry
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00002400
Study ID Number: 228C
ClinicalTrials.gov Identifier: NCT00002400
Health Authority: United States: Food and Drug Administration
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00002400
