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A Phase II Double-Blind Study of Delavirdine Mesylate ( U-90152 ) in Combination With Zidovudine ( AZT ) and/or Didanosine ( ddI ) Versus AZT and ddI Combination Therapy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000803
First Posted: August 31, 2001
Last Update Posted: April 4, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
November 2, 1999
August 31, 2001
April 4, 2012
Not Provided
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Complete list of historical versions of study NCT00000803 on ClinicalTrials.gov Archive Site
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A Phase II Double-Blind Study of Delavirdine Mesylate ( U-90152 ) in Combination With Zidovudine ( AZT ) and/or Didanosine ( ddI ) Versus AZT and ddI Combination Therapy
A Phase II Double-Blind Study of Delavirdine Mesylate ( U-90152 ) in Combination With Zidovudine ( AZT ) and/or Didanosine ( ddI ) Versus AZT and ddI Combination Therapy

To determine the safety and anti-HIV activity of delavirdine mesylate ( U-90152 ) in combination with zidovudine ( AZT ) and/or didanosine ( ddI ) versus AZT/ddI combination.

U-90152 has demonstrated anti-HIV activity. Since the combination of this drug with either AZT or ddI has synergistic inhibitory activity against HIV-1 in vitro, and triple therapy appears to have greater inhibitory activity against HIV-1 in vitro than dual therapy, the use of U-90152 in combination with AZT and/or ddI may improve the benefits of these drugs in persons with HIV disease.

U-90152 has demonstrated anti-HIV activity. Since the combination of this drug with either AZT or ddI has synergistic inhibitory activity against HIV-1 in vitro, and triple therapy appears to have greater inhibitory activity against HIV-1 in vitro than dual therapy, the use of U-90152 in combination with AZT and/or ddI may improve the benefits of these drugs in persons with HIV disease.

Patients are randomized to receive U-90152/AZT/ddI, U-90152/AZT, U-90152/ddI, or AZT/ddI for 48 weeks.

Interventional
Phase 2
Masking: Double
Primary Purpose: Treatment
HIV Infections
  • Drug: Delavirdine mesylate
  • Drug: Zidovudine
  • Drug: Didanosine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
471
March 1997
Not Provided

Inclusion Criteria

Concurrent Medication:

Required:

  • PCP prophylaxis for patients with CD4 count <= 200 cells/mm3.

Allowed:

  • Topical antifungal agents.
  • Oral ketoconazole, fluconazole, and itraconazole for candidiasis or disseminated fungal infections.
  • Isoniazid, ethambutol, pyrazinamide, clofazimine, ciprofloxacin, and clarithromycin for acute or maintenance therapy for mycobacterial disease (also clarithromycin for MAC prophylaxis).
  • Acute or maintenance therapy for toxoplasmosis.
  • Acute or maintenance therapy with acyclovir (no more than 1000 mg/day) for herpes simplex virus infection.
  • rEPO and rG-CSF.
  • Antibiotics for bacterial infections (except rifampin and rifabutin).
  • Antipyretics, analgesics, nonsteroidal anti-inflammatory agents, antiemetics, and methadone.

Concurrent Treatment:

Allowed for cutaneous Kaposi's sarcoma:

  • Localized radiation therapy.
  • Limited intralesional therapy.

Patients must have:

  • HIV infection.
  • CD4 count 100 - 500 cells/mm3.
  • Prior cumulative monotherapy of <= 6 months (may have taken either AZT or ddI, but not both) OR no prior antiretroviral therapy.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

  • Malignancy (other than basal or squamous cell carcinoma of the skin, Stage 1 or 2 cervical intraepithelial neoplasia, or minimal Kaposi's sarcoma).
  • Considered to be unlikely to comply with study requirements.

Concurrent Medication:

Excluded:

  • Antiretroviral therapies and biologic response modifiers (except for study medications, rEPO, and rG-CSF).
  • Rifampin.
  • Rifabutin.
  • Terfenadine.
  • Astemizole.
  • Loratadine.
  • Quinidine.
  • Digitoxin.
  • Systemic corticosteroids for more than 21 consecutive days.
  • Foscarnet.
  • Systemic cytotoxic chemotherapy for a malignancy.

Patients with the following prior conditions are excluded:

  • History of intolerance to AZT at <= 600 mg/day or ddI at <= 400 mg/day or discontinuation of either drug for toxicity.
  • History of intolerance to trifluoperazine or piperazine citrate (per amendment).
  • History of pancreatitis.
  • History of grade 2 or worse peripheral neuropathy.
  • Unexplained temperature >= 38.5 C on any 7 days within the past 30 days.
  • Chronic diarrhea on any 15 days during the past 30 days.

Prior Medication:

Excluded:

  • Prior foscarnet as induction or maintenance therapy.
  • Prior U-90152.
  • Prior ddC or d4T.
  • Prior AZT/ddI in combination or taken separately at different times.
  • Prior non-nucleoside reverse transcriptase inhibitors (nevirapine, atevirdine, etc.).
  • Prior protease inhibitors (although patients from ACTG 282 are eligible).
  • HIV-1 vaccine within the past 21 days.
  • Acute treatment for a serious infection or for any opportunistic infection within the past 14 days.

Excluded within the past 30 days:

  • Interferon or interleukin.
  • Rifampin.
  • Rifabutin.
  • Terfenadine.
  • Astemizole.
  • Loratadine.
  • Recombinant EPO or G-CSF.
  • Hydroxyurea.
  • SPV-30.
  • Any other investigational drug.

Active drug or alcohol use.

Sexes Eligible for Study: All
13 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Puerto Rico,   United States
 
 
NCT00000803
ACTG 261
11238 ( Registry Identifier: DAIDS-ES Registry Number )
Not Provided
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National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Allergy and Infectious Diseases (NIAID)
Not Provided
Study Chair: Friedland G
Study Chair: Fischl MA
Study Chair: Pollard R
National Institute of Allergy and Infectious Diseases (NIAID)
April 2012

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