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A Study of Delavirdine Used Together With Other Anti-HIV Drugs in HIV-Infected Patients

NCT ID: NCT00002401

Last Updated: 2005-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Brief Summary

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The purpose of this study is to see if it is safe and effective to give delavirdine (DLV) in combination with two or three other drugs to HIV-infected patients. The drugs to be used in combination with DLV are zidovudine (ZDV), indinavir (IDV), and lamivudine (3TC).

Detailed Description

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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.

Conditions

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HIV Infections

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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Indinavir sulfate

Intervention Type DRUG

Delavirdine mesylate

Intervention Type DRUG

Lamivudine

Intervention Type DRUG

Zidovudine

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pharmacia and Upjohn

INDUSTRY

Sponsor Role lead

Locations

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Pharmacia & Upjohn

Peapack, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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0074

Identifier Type: -

Identifier Source: secondary_id

228F

Identifier Type: -

Identifier Source: org_study_id