Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Double-Blind, Randomized, Comparative Study of Delavirdine Mesylate (U-90152S) in Combination With Didanosine (ddI) Versus ddI Alone in HIV-1 Infected Individuals With CD4 Counts of <= 300/mm3

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002123
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: November 1996

November 2, 1999
June 23, 2005
Not Provided
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00002123 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Double-Blind, Randomized, Comparative Study of Delavirdine Mesylate (U-90152S) in Combination With Didanosine (ddI) Versus ddI Alone in HIV-1 Infected Individuals With CD4 Counts of <= 300/mm3
A Double-Blind, Randomized, Comparative Study of Delavirdine Mesylate (U-90152S) in Combination With Didanosine (ddI) Versus ddI Alone in HIV-1 Infected Individuals With CD4 Counts of <= 300/mm3

To evaluate the safety, tolerance, pharmacokinetics, and efficacy of delavirdine mesylate (U-90152S) in combination with didanosine (ddI) versus ddI alone in HIV-positive patients.

Not Provided
Interventional
Phase 3
Endpoint Classification: Safety Study
Masking: Double-Blind
Primary Purpose: Treatment
HIV Infections
  • Drug: Delavirdine mesylate
  • Drug: Didanosine
Not Provided
Freimuth WW, Chuang-Stein CJ, Greenwald CA, Cox SR, Edge-Padbury BA, Carberry PA, Wathen LK. Delavirdine (DLV) + didanosine (ddI) combination therapy has sustained surrogate marker response in advanced HIV-1 population. Conf Retroviruses Opportunistic Infect. 1996 Jan 28-Feb 1;3rd:163

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
Not Provided
Not Provided

Inclusion Criteria

Concurrent Medication:

Allowed:

  • AZT.

Patients must have:

  • HIV-1 seropositivity.
  • CD4 count <= 300 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.

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 ddI in previous treated patients.

Prior Medication:

Excluded:

  • More than 4 months total of prior ddI.
  • Any prior ddC, d4T, or 3TC.
  • Prior nonnucleoside 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.

Required:

  • AZT therapy at some time prior to screening. Active substance abuse.
Both
14 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico
 
NCT00002123
228A, M/3331/0017
Not Provided
Not Provided
Pharmacia and Upjohn
Not Provided
Not Provided
NIH AIDS Clinical Trials Information Service
November 1996

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