A Double-Blind, Randomized, Dose Response Study of Three Doses of Delavirdine Mesylate (U-90152S) in Combination With Zidovudine (ZDV) Versus ZDV Alone in HIV-1 Infected Individuals With CD4 Counts of 200-500mm3

June 23, 2005 updated by: Pharmacia and Upjohn

PART I: To evaluate the safety, tolerance, efficacy, and pharmacokinetics of three fixed doses of delavirdine mesylate (DLV) in combination with zidovudine (AZT) versus AZT alone in HIV-positive patients.

PART II: To evaluate the safety, tolerance, efficacy, and pharmacokinetics of ZDV plus 3TC with or without DLV versus ZDV plus DLV in HIV-positive patients.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

PART I: Patients are originally randomized to receive ZDV plus DLV (DLV at 1 of 3 doses) or ZDV plus placebo.

AS PER AMENDMENT 3/7/96:

PART II: Patients are rerandomized from PART I. Arm I: ZDV plus 3TC plus placebo. Arm II: ZDV plus 3TC plus DLV. Arm III: ZDV plus DLV (DLV at a higher dose than in the original protocol). Arm IV: ZDV plus DLV (no change from original; same treatment as Arm III).

AS PER AMENDMENT 1/24/97: Approximately 450 more patients will be enrolled in one of these 3 revised arms on PART II. Half of these new patients will be anti-retroviral naive and half will be anti-retroviral experienced.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1250

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • San Juan, Puerto Rico, 00936
        • UPR School of Medicine
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 352942041
        • Univ of Alabama at Birmingham
    • California
      • Berkeley, California, United States, 94705
        • East Bay AIDS Ctr
      • Clovis, California, United States, 93612
        • Peachwood Med Ctr
      • Los Angeles, California, United States, 90095
        • CARE Ctr / UCLA Med Ctr
      • Los Angeles, California, United States, 900331079
        • Los Angeles County - USC Med Ctr
      • Los Angeles, California, United States, 90059
        • Los Angeles County / Health Research Assoc / Drew Med Ctr
      • Oakland, California, United States, 946021018
        • Highland Gen Hosp / San Francisco Gen Hosp
      • Orange, California, United States, 92668
        • UCI Med Ctr
      • Redwood City, California, United States, 94063
        • AIDS Community Research Consortium
      • Sacramento, California, United States, 95817
        • UCD Med Ctr / AIDS and Related Disorders Clinic
      • San Diego, California, United States, 92101
        • St Lukes Medical Group
      • San Diego, California, United States, 92103
        • UCSD / Ctr for Special Immunology
      • San Francisco, California, United States, 94114
        • Davies Med Ctr
      • San Francisco, California, United States, 94103
        • ViRx Inc
      • San Francisco, California, United States, 94109
        • Saint Francis Mem Hosp
      • Tarzana, California, United States, 91356
        • Shared Med Research Foundation
      • Torrance, California, United States, 90509
        • Harbor - UCLA Med Ctr
    • Colorado
      • Denver, Colorado, United States, 80262
        • Univ Hosp / Univ of Colorado Health Sci Ctr
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
        • George Washington Univ Med Ctr
      • Washington, District of Columbia, United States, 20007
        • Georgetown Univ Med Ctr
    • Florida
      • Miami, Florida, United States, 33136
        • Univ of Miami School of Medicine
      • Palm Beach Gardens, Florida, United States, 33410
        • Caremark Inc
      • Tampa, Florida, United States, 33614
        • Infectious Disease Research Institute Inc
    • Georgia
      • Atlanta, Georgia, United States, 30345
        • Infectious Disease Rsch Consortium of GA / SE Clin Resources
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush Presbyterian - Saint Luke's Med Ctr
      • Chicago, Illinois, United States, 60612
        • Univ of Illinois
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana Univ Infectious Disease Research Clinic
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Univ of Iowa
    • Kansas
      • Kansas City, Kansas, United States, 661607354
        • Univ of Kansas School of Medicine / Univ Hosp
      • Wichita, Kansas, United States, 67214
        • Univ of Kansas School of Medicine
    • Kentucky
      • Lexington, Kentucky, United States, 405360084
        • Univ of Kentucky Med Ctr / Chandler Med Ctr
    • Louisiana
      • New Orleans, Louisiana, United States, 701122699
        • Tulane Univ Med School
    • Maine
      • Portland, Maine, United States, 04102
        • AIDS Consultation Service / Maine Med Ctr
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Univ of Maryland at Baltimore
      • Baltimore, Maryland, United States, 212052196
        • Johns Hopkins Hosp
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hosp
      • Boston, Massachusetts, United States, 02215
        • New England Deaconess Hosp
      • Boston, Massachusetts, United States, 02114
        • Massachusetts Gen Hosp
      • Boston, Massachusetts, United States, 02118
        • Boston City Hosp / FGH-1
      • Springfield, Massachusetts, United States, 01199
        • Baystate Med Ctr of Springfield
      • Worcester, Massachusetts, United States, 01655
        • Univ of Massachusetts Med Ctr
    • Michigan
      • Ann Arbor, Michigan, United States, 481090378
        • Univ of Michigan Hospitals and Health Ctrs
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hosp
      • Detroit, Michigan, United States, 48201
        • Harper Hosp
    • Minnesota
      • St. Paul, Minnesota, United States, 55101
        • St Paul Ramsey Med Ctr / HIV Program Office
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Univ of Missouri at Kansas City School of Medicine
      • St. Louis, Missouri, United States, 63110
        • Washington Univ
    • Nebraska
      • Omaha, Nebraska, United States, 681985130
        • Univ of Nebraska Med Ctr / HIV Clinic
    • New Jersey
      • Neptune, New Jersey, United States, 07753
        • Jersey Shore Med Ctr
    • New York
      • Albany, New York, United States, 122083479
        • Albany Med College
      • Buffalo, New York, United States, 14215
        • SUNY / Erie County Med Ctr at Buffalo
      • New York, New York, United States, 10003
        • Beth Israel Med Ctr
      • New York, New York, United States, 10029
        • Mount Sinai Med Ctr
      • New York, New York, United States, 10001
        • Community Research Initiative on AIDS
      • New York, New York, United States, 10021
        • New York Hosp - Cornell Med Ctr
      • New York, New York, United States, 10011
        • Saint Vincent's Hosp and Med Ctr
      • Rochester, New York, United States, 14642
        • Univ of Rochester Med Ctr
      • Rochester, New York, United States, 14620
        • Community Health Network
      • Stony Brook, New York, United States, 117948153
        • SUNY / Health Sciences Ctr at Stony Brook
      • Valhalla, New York, United States, 10595
        • New York Med College / Westchester County Med Ctr
    • North Carolina
      • Chapel Hill, North Carolina, United States, 275997215
        • Univ of North Carolina School of Medicine
      • Charlotte, North Carolina, United States, 28204
        • Carolinas Med Ctr
      • Durham, North Carolina, United States, 27710
        • Duke Univ Med Ctr
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • Univ of Cincinnati / Holmes Hosp
      • Cleveland, Ohio, United States, 44106
        • Univ Hosp of Cleveland / Case Western Reserve Univ
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73117
        • Univ of Oklahoma
    • Oregon
      • Portland, Oregon, United States, 97210
        • Portland Veterans Adm Med Ctr / Rsch & Education Grp
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Pennsylvania State Univ / Hershey Med Ctr
      • Philadelphia, Pennsylvania, United States, 19107
        • Buckley Braffman Stern Med Associates
      • Philadelphia, Pennsylvania, United States, 19104
        • Univ of Pennsylvania / HIV Clinic
      • Philadelphia, Pennsylvania, United States, 19146
        • Oncology and Hematology Association
      • Pittsburgh, Pennsylvania, United States, 15261
        • Univ of Pittsburgh Med School
    • Rhode Island
      • Cranston, Rhode Island, United States, 02910
        • Stratogen Health / Independent Research Nurses
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Med Univ of South Carolina
    • Tennessee
      • Memphis, Tennessee, United States, 38163
        • Univ of Tennessee
      • Nashville, Tennessee, United States, 37212
        • Vanderbilt Univ
    • Texas
      • Austin, Texas, United States, 78751
        • Central Texas Med Foundation
      • Dallas, Texas, United States, 75216
        • Dallas Veterans Administration Med Ctr
      • Houston, Texas, United States, 77030
        • Houston Veterans Administration Med Ctr
      • Houston, Texas, United States, 77004
        • Park Plaza Hosp
      • Houston, Texas, United States, 77030
        • Univ TX Health Science Ctr
      • San Antonio, Texas, United States, 78284
        • Audie L Murphy Veterans Administration Hosp
    • Vermont
      • Burlington, Vermont, United States, 05401
        • Med Ctr of Vermont Hosp
    • Virginia
      • Hampton, Virginia, United States, 23666
        • Hampton Roads Med Specialists
      • Richmond, Virginia, United States, 23219
        • Richmond AIDS Consortium
    • Washington
      • Seattle, Washington, United States, 98104
        • Univ of Washington
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Univ of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

Patients must have:

  • HIV-1 seropositivity.
  • CD4 count 200-500 cells/mm3.
  • No active or acute (onset within the past month) opportunistic infections such as active cryptococcosis, pneumocystis carinii, herpes zoster, histoplasmosis, or cytomegalovirus (CMV).
  • Consent of parent or guardian if less than 18 years of age.
  • Understanding of potential risk to fetus related to study participation.
  • Acceptable medical history, physical exam, EKG, and chest x-ray during screening.

NOTE:

  • Patients with cutaneous Kaposi's sarcoma requiring no systemic therapy are permitted.

PER AMENDMENT 3/7/96:

  • ZDV therapy for 0-6 months prior to study entry. (Part II)

Prior Medication:

Allowed:

  • Prior AZT (no more than 6 months total).

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

  • Active tuberculosis that is sensitive to rifampin.
  • Inability to swallow numerous tablets.
  • Clinically significant active or acute medical problems, including progressive multifocal leukoencephalopathy, lymphoma, or malignancy requiring systemic therapy.
  • Clinically significant hypersensitivity to piperazine-type drugs (e.g., Antepar and Stelazine).
  • Grade 2 or worse baseline organ function. NOTE:
  • Hemophiliacs with grade 2 bilirubin, alkaline phosphatase, SGOT, or SGPT will be considered if these values have been stable over the past year. NOTE:
  • Patients with suspected Gilbert's syndrome will be considered if bilirubin is grade 2 or better.

Patients with the following prior conditions are excluded:

  • History of pancreatitis within the past 2 years.
  • History of clinically significant nervous system or muscle disease, seizure disorder, AIDS dementia, or psychiatric disorder that would preclude study compliance.
  • History of grade 2 or worse peripheral neuropathy.
  • Intolerance to AZT in previously treated patients.

Prior Medication:

Excluded:

  • More than 6 months total of prior AZT.
  • Any prior ddC, d4T, 3TC, or ddI.
  • Prior non-nucleoside reverse transcriptase inhibitors, including L-drugs, nevirapine, TIBO, HEPT, delavirdine, atevirdine, and alpha-APA.
  • Other investigational antiretroviral medications (including foscarnet) or immunomodulators (including all interferons) within 21 days prior to initial study drug dose.
  • Prior prophylactic or therapeutic HIV-1 gp120 or 160 vaccines.
  • Rifampin, rifabutin, astemizole, loratadine, or terfenadine within 21 days prior to initial study drug dose.
  • Any unapproved investigational medication for any indication within 21 days prior to initial study drug dose.
  • Any enzyme-inducing drugs known to affect cytochrome P450 3A, (e.g., ketoconazole, fluconazole, isoniazid, itraconazole, etc.) within 21 days prior to initial study drug dose.

Active substance abuse.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pharmacia and Upjohn

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 2, 1999

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 30, 2001

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 24, 2005

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 23, 2005

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 1997

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 228B
  • M/3331/0021

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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