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 - Article Azidothymidine Capsule; AZT Capsule; Compound S Capsule; Retrovir Capsule
Clinical Trial: 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
This study has been completed.
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.
|Condition||Treatment or Intervention||Phase|
|HIV Infections || Drug: Delavirdine mesylate |
|Phase III |
MedlinePlus related topics: AIDS
Study Type: Interventional
Study Design: Treatment, Double-Blind, Safety Study
Expected Total Enrollment: 1250
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.
Ages Eligible for Study: 14 Years and above, Genders Eligible for Study: Both
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).
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.
Univ of Alabama at Birmingham, Birmingham, Alabama, 352942041, United States
Peachwood Med Ctr, Clovis, California, 93612, United States
ViRx Inc, San Francisco, California, 94103, United States
AIDS Community Research Consortium, Redwood City, California, 94063, United States
Highland Gen Hosp / San Francisco Gen Hosp, Oakland, California, 946021018, United States
UCD Med Ctr / AIDS and Related Disorders Clinic, Sacramento, California, 95817, United States
East Bay AIDS Ctr, Berkeley, California, 94705, United States
Los Angeles County - USC Med Ctr, Los Angeles, California, 900331079, United States
Harbor - UCLA Med Ctr, Torrance, California, 90509, United States
Shared Med Research Foundation, Tarzana, California, 91356, United States
UCSD / Ctr for Special Immunology, San Diego, California, 92103, United States
Los Angeles County / Health Research Assoc / Drew Med Ctr, Los Angeles, California, 90059, United States
Saint Francis Mem Hosp, San Francisco, California, 94109, United States
St Lukes Medical Group, San Diego, California, 92101, United States
CARE Ctr / UCLA Med Ctr, Los Angeles, California, 90095, United States
UCI Med Ctr, Orange, California, 92668, United States
Davies Med Ctr, San Francisco, California, 94114, United States
Univ Hosp / Univ of Colorado Health Sci Ctr, Denver, Colorado, 80262, United States
District of Columbia
George Washington Univ Med Ctr, Washington, District of Columbia, 20037, United States
Georgetown Univ Med Ctr, Washington, District of Columbia, 20007, United States
Univ of Miami School of Medicine, Miami, Florida, 33136, United States
Caremark Inc, Palm Beach Gardens, Florida, 33410, United States
Infectious Disease Research Institute Inc, Tampa, Florida, 33614, United States
Infectious Disease Rsch Consortium of GA / SE Clin Resources, Atlanta, Georgia, 30345, United States
Rush Presbyterian - Saint Luke's Med Ctr, Chicago, Illinois, 60612, United States
Univ of Illinois, Chicago, Illinois, 60612, United States
Indiana Univ Infectious Disease Research Clinic, Indianapolis, Indiana, 46202, United States
Univ of Iowa, Iowa City, Iowa, 52242, United States
Univ of Kansas School of Medicine / Univ Hosp, Kansas City, Kansas, 661607354, United States
Univ of Kansas School of Medicine, Wichita, Kansas, 67214, United States
Univ of Kentucky Med Ctr / Chandler Med Ctr, Lexington, Kentucky, 405360084, United States
Tulane Univ Med School, New Orleans, Louisiana, 701122699, United States
AIDS Consultation Service / Maine Med Ctr, Portland, Maine, 04102, United States
Johns Hopkins Hosp, Baltimore, Maryland, 212052196, United States
Univ of Maryland at Baltimore, Baltimore, Maryland, 21201, United States
Massachusetts Gen Hosp, Boston, Massachusetts, 02114, United States
Univ of Massachusetts Med Ctr, Worcester, Massachusetts, 01655, United States
New England Deaconess Hosp, Boston, Massachusetts, 02215, United States
Boston City Hosp / FGH-1, Boston, Massachusetts, 02118, United States
Brigham and Women's Hosp, Boston, Massachusetts, 02115, United States
Baystate Med Ctr of Springfield, Springfield, Massachusetts, 01199, United States
Harper Hosp, Detroit, Michigan, 48201, United States
Univ of Michigan Hospitals and Health Ctrs, Ann Arbor, Michigan, 481090378, United States
Henry Ford Hosp, Detroit, Michigan, 48202, United States
St Paul Ramsey Med Ctr / HIV Program Office, St. Paul, Minnesota, 55101, United States
Washington Univ, St. Louis, Missouri, 63110, United States
Univ of Missouri at Kansas City School of Medicine, Kansas City, Missouri, 64108, United States
Univ of Nebraska Med Ctr / HIV Clinic, Omaha, Nebraska, 681985130, United States
Jersey Shore Med Ctr, Neptune, New Jersey, 07753, United States
New York Med College / Westchester County Med Ctr, Valhalla, New York, 10595, United States
Saint Vincent's Hosp and Med Ctr, New York, New York, 10011, United States
Univ of Rochester Med Ctr, Rochester, New York, 14642, United States
Albany Med College, Albany, New York, 122083479, United States
SUNY / Health Sciences Ctr at Stony Brook, Stony Brook, New York, 117948153, United States
Community Research Initiative on AIDS, New York, New York, 10001, United States
Community Health Network, Rochester, New York, 14620, United States
SUNY / Erie County Med Ctr at Buffalo, Buffalo, New York, 14215, United States
Beth Israel Med Ctr, New York, New York, 10003, United States
New York Hosp - Cornell Med Ctr, New York, New York, 10021, United States
Mount Sinai Med Ctr, New York, New York, 10029, United States
Carolinas Med Ctr, Charlotte, North Carolina, 28204, United States
Univ of North Carolina School of Medicine, Chapel Hill, North Carolina, 275997215, United States
Duke Univ Med Ctr, Durham, North Carolina, 27710, United States
Univ Hosp of Cleveland / Case Western Reserve Univ, Cleveland, Ohio, 44106, United States
Univ of Cincinnati / Holmes Hosp, Cincinnati, Ohio, 45267, United States
Univ of Oklahoma, Oklahoma City, Oklahoma, 73117, United States
Portland Veterans Adm Med Ctr / Rsch & Education Grp, Portland, Oregon, 97210, United States
Univ of Pennsylvania / HIV Clinic, Philadelphia, Pennsylvania, 19104, United States
Pennsylvania State Univ / Hershey Med Ctr, Hershey, Pennsylvania, 17033, United States
Buckley Braffman Stern Med Associates, Philadelphia, Pennsylvania, 19107, United States
Oncology and Hematology Association, Philadelphia, Pennsylvania, 19146, United States
Univ of Pittsburgh Med School, Pittsburgh, Pennsylvania, 15261, United States
Stratogen Health / Independent Research Nurses, Cranston, Rhode Island, 02910, United States
Med Univ of South Carolina, Charleston, South Carolina, 29425, United States
Vanderbilt Univ, Nashville, Tennessee, 37212, United States
Univ of Tennessee, Memphis, Tennessee, 38163, United States
Audie L Murphy Veterans Administration Hosp, San Antonio, Texas, 78284, United States
Park Plaza Hosp, Houston, Texas, 77004, United States
Houston Veterans Administration Med Ctr, Houston, Texas, 77030, United States
Univ TX Health Science Ctr, Houston, Texas, 77030, United States
Dallas Veterans Administration Med Ctr, Dallas, Texas, 75216, United States
Central Texas Med Foundation, Austin, Texas, 78751, United States
Med Ctr of Vermont Hosp, Burlington, Vermont, 05401, United States
Richmond AIDS Consortium, Richmond, Virginia, 23219, United States
Hampton Roads Med Specialists, Hampton, Virginia, 23666, United States
Univ of Washington, Seattle, Washington, 98104, United States
Univ of Wisconsin, Madison, Wisconsin, 53792, United States
UPR School of Medicine, San Juan, 00936, Puerto Rico
Record last reviewed: July 1997
Last Updated: October 13, 2004
Record first received: November 2, 1999
ClinicalTrials.gov Identifier: NCT00002124
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Cache Date: April 9, 2005