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A Study to Find the Best Dosing Schedule for Delavirdine, Zidovudine, and Indinavir in HIV-Positive Patients

NCT ID: NCT00002236

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

32 participants

Study Classification

INTERVENTIONAL

Brief Summary

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The purpose of this study is to see whether it is better to take delavirdine (DLV) plus indinavir (IDV) plus zidovudine (ZDV) twice a day or three times a day.

Detailed Description

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Patients are divided into 2 treatment groups; the groups are balanced with respect to viral load. Group A receives ZDV, DLV, and IDV 3 times daily. Group B receives ZDV, DLV, and IDV 2 times daily. Patients are evaluated for changes from baseline in viral load and CD4 cell count.

Conditions

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HIV Infections

Study Design

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Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Indinavir sulfate

Intervention Type DRUG

Delavirdine mesylate

Intervention Type DRUG

Zidovudine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

You may be eligible for this study if you:

* Are HIV-positive.
* Have a viral load (level of HIV in the blood) of at least 20,000 copies/ml.
* Have a CD4 cell count of at least 50 cells/mm3.
* Are at least 14 years old (consent of parent or guardian is required if under 18).

Exclusion Criteria

You will not be eligible for this study if you:

* Have ever taken an anti-HIV drug other than ZDV.
* Have taken ZDV for more than 1 month.
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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AIDS Healthcare Foundation

Los Angeles, California, United States

Site Status

UCSF AIDS Research Institute

San Francisco, California, United States

Site Status

Saint Luke's - Roosevelt Hosp Ctr

New York, New York, United States

Site Status

Anderson Clinical Research

Pittsburgh, Pennsylvania, United States

Site Status

Univ of Tennessee / Div of Infect Dis / Dept of Med

Memphis, Tennessee, United States

Site Status

Infectious Disease Physicians Inc

Annandale, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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M/3331/0072

Identifier Type: -

Identifier Source: secondary_id

228G

Identifier Type: -

Identifier Source: org_study_id