Search / Trial NCT00002124

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

Launched by PHARMACIA AND UPJOHN · Aug 30, 2001

Trial Information

Current as of November 03, 2024

Completed

Keywords

Drug Therapy, Combination Acquired Immunodeficiency Syndrome Aids Related Complex Antiviral Agents Zidovudine

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 ant...

Gender

ALL

Eligibility criteria

  • 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.

About Pharmacia And Upjohn

Pharmacia and Upjohn, a global biopharmaceutical company, specializes in the research, development, and commercialization of innovative therapies that address unmet medical needs across multiple therapeutic areas. With a strong commitment to advancing healthcare, the company leverages cutting-edge science and technology to improve patient outcomes. Pharmacia and Upjohn is dedicated to conducting rigorous clinical trials that adhere to the highest ethical standards, ensuring the safety and efficacy of its products while fostering collaboration with healthcare professionals and regulatory authorities worldwide. Through its comprehensive portfolio, the company aims to enhance the quality of life for patients and contribute to the advancement of medical science.

Locations

New York, New York, United States

Los Angeles, California, United States

Birmingham, Alabama, United States

Springfield, Massachusetts, United States

New York, New York, United States

New York, New York, United States

Houston, Texas, United States

Houston, Texas, United States

Chicago, Illinois, United States

Seattle, Washington, United States

New Orleans, Louisiana, United States

Detroit, Michigan, United States

Worcester, Massachusetts, United States

Charleston, South Carolina, United States

Oakland, California, United States

Washington, District Of Columbia, United States

Miami, Florida, United States

Buffalo, New York, United States

New York, New York, United States

Durham, North Carolina, United States

Philadelphia, Pennsylvania, United States

San Francisco, California, United States

Washington, District Of Columbia, United States

Wichita, Kansas, United States

Cleveland, Ohio, United States

San Antonio, Texas, United States

Richmond, Virginia, United States

Chicago, Illinois, United States

Portland, Oregon, United States

Baltimore, Maryland, United States

Boston, Massachusetts, United States

Baltimore, Maryland, United States

Rochester, New York, United States

Torrance, California, United States

Redwood City, California, United States

Detroit, Michigan, United States

New York, New York, United States

Valhalla, New York, United States

Los Angeles, California, United States

Boston, Massachusetts, United States

Charlotte, North Carolina, United States

Dallas, Texas, United States

Chapel Hill, North Carolina, United States

Stony Brook, New York, United States

San Francisco, California, United States

San Francisco, California, United States

Tampa, Florida, United States

Berkeley, California, United States

Orange, California, United States

Boston, Massachusetts, United States

Kansas City, Missouri, United States

Philadelphia, Pennsylvania, United States

Austin, Texas, United States

San Juan, , Puerto Rico

Memphis, Tennessee, United States

Tarzana, California, United States

Houston, Texas, United States

San Diego, California, United States

Omaha, Nebraska, United States

Rochester, New York, United States

Hampton, Virginia, United States

St. Paul, Minnesota, United States

St. Louis, Missouri, United States

Los Angeles, California, United States

Sacramento, California, United States

San Diego, California, United States

Denver, Colorado, United States

Palm Beach Gardens, Florida, United States

Atlanta, Georgia, United States

Indianapolis, Indiana, United States

Iowa City, Iowa, United States

Kansas City, Kansas, United States

Lexington, Kentucky, United States

Portland, Maine, United States

Boston, Massachusetts, United States

Ann Arbor, Michigan, United States

Neptune, New Jersey, United States

Albany, New York, United States

Cincinnati, Ohio, United States

Hershey, Pennsylvania, United States

Philadelphia, Pennsylvania, United States

Pittsburgh, Pennsylvania, United States

Nashville, Tennessee, United States

Burlington, Vermont, United States

Madison, Wisconsin, United States

Clovis, California, United States

Oklahoma City, Oklahoma, United States

Cranston, Rhode Island, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

Similar Trials