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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


Phase 2
13 Years
N/A
Not Enrolling
Both
HIV Infections

Thank you

Trial Information

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


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.

Inclusion Criteria


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Masking: Double-Blind, Primary Purpose: Treatment

Principal Investigator

Friedland G

Investigator Role:

Study Chair

Authority:

United States: Federal Government

Study ID:

ACTG 261

NCT ID:

NCT00000803

Start Date:

Completion Date:

March 1997

Related Keywords:

  • HIV Infections
  • Didanosine
  • Drug Therapy, Combination
  • Acquired Immunodeficiency Syndrome
  • AIDS-Related Complex
  • Antiviral Agents
  • Zidovudine
  • HIV Infections
  • Acquired Immunodeficiency Syndrome

Name

Location

Alabama Therapeutics CRSBirmingham, Alabama  35294
USC CRSLos Angeles, California  90033
Stanford CRSPalo Alto, California  94305
Ucsd, Avrc CrsSan Diego, California  
Ucsf Aids CrsSan Francisco, California  
University of Colorado Hospital CRSAurora, Colorado  80262
Howard University Hosp., Div. of Infectious Diseases, ACTUWashington, District of Columbia  20059
Univ. of Miami AIDS CRSMiami, Florida  33136
Univ. of Hawaii at Manoa, Leahi Hosp.Honolulu, Hawaii  96816
Indiana Univ. School of Medicine, Infectious Disease Research ClinicIndianapolis, Indiana  46202
Methodist Hosp. of IndianaIndianapolis, Indiana  46202
Johns Hopkins Adult AIDS CRSBaltimore, Maryland  21287
Massachusetts General Hospital ACTG CRSBoston, Massachusetts  02114
Beth Israel Deaconess - East Campus A0102 CRSBoston, Massachusetts  02215
Beth Israel Deaconess Med. Ctr., ACTG CRSBoston, Massachusetts  02215
Bmc Actg CrsBoston, Massachusetts  02118
University of Minnesota, ACTUMinneapolis, Minnesota  
St. Louis ConnectCare, Infectious Diseases ClinicSt Louis, Missouri  63112
Washington U CRSSt. Louis, Missouri  
SUNY - Buffalo, Erie County Medical Ctr.Buffalo, New York  14215
NY Univ. HIV/AIDS CRSNew York, New York  10016
Memorial Sloan-Kettering Cancer Ctr.New York, New York  10021
Cornell University A2201New York, New York  10021
Beth Israel Med. Ctr. (Mt. Sinai)New York, New York  10003
Univ. of Rochester ACTG CRSRochester, New York  14642
Univ. of Cincinnati CRSCincinnati, Ohio  45267
Case CRSCleveland, Ohio  44106
The Ohio State Univ. AIDS CRSColumbus, Ohio  43210
Hosp. of the Univ. of Pennsylvania CRSPhiladelphia, Pennsylvania  19104
University of Washington AIDS CRSSeattle, Washington  98122
Queens Med. Ctr.Honolulu, Hawaii  96816