Trial Search Results

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Stanford Investigator(s):


  • Drug: Delavirdine mesylate
  • Drug: Zidovudine
  • Drug: Didanosine


Phase 2


Inclusion Criteria

Concurrent Medication:


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


   - 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

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:


   - 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:


   - 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.

Ages Eligible for Study

13 Years - N/A

Genders Eligible for Study


Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Not Recruiting