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NCT00002400 Clinical Trial

A Study of Two Anti-HIV Drug Combinations in HIV-Infected Patients

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00002400
Other study ID # 228C
Secondary ID 0063
Status Completed
Phase N/A
First received November 2, 1999
Last updated June 23, 2005

Study information
Verified date January 1999
Source NIH AIDS Clinical Trials Information Service
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 45
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Endpoint Classification: Safety Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Indinavir sulfate

• Delavirdine mesylate

• Lamivudine

• Zidovudine

Locations
Country Name City State
United States Pharmacia & Upjohn Peapack New Jersey

Sponsors (1)
Lead Sponsor Collaborator
Pharmacia and Upjohn

Country where clinical trial is conducted

United States, 

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