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:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00000803
First received: November 2, 1999
Last updated: April 2, 2012
Last verified: April 2012

November 2, 1999
April 2, 2012
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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
Endpoint Classification: Safety Study
Masking: Double-Blind
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.

Both
13 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico
 
NCT00000803
ACTG 261, 11238
Not Provided
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