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

NCT ID: NCT00002400

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

45 participants

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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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.

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

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.
Minimum Eligible Age

18 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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0063

Identifier Type: -

Identifier Source: secondary_id

228C

Identifier Type: -

Identifier Source: org_study_id