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.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002124
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: July 1997

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00002124 on ClinicalTrials.gov Archive Site
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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
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

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.

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.

Interventional
Phase 3
Endpoint Classification: Safety Study
Masking: Double-Blind
Primary Purpose: Treatment
HIV Infections
  • Drug: Delavirdine mesylate
  • Drug: Lamivudine
  • Drug: Zidovudine
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1250
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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.

Both
14 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico
 
NCT00002124
228B, M/3331/0021
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Pharmacia and Upjohn
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NIH AIDS Clinical Trials Information Service
July 1997

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP