Phase II Study of the Safety and Surrogate Marker Efficacy of Butyldeoxynojirimycin (SC-48334) and AZT in Symptomatic HIV-1 Infected Patients With 200 - 500 CD4+ Cells/mm3. (NOTE: Asymptomatic HIV-1 Infected Patients Also Eligible)

To assess the dose-related antiviral effects of SC-48334 and zidovudine (AZT) administered in combination or individually in HIV-1 positive patients with 200 - 500 CD4+ cells/mm3. To determine the safety of escalating doses of SC-48334 when administered in combination with any of three doses of AZT to symptomatic HIV-1 positive patients with 200 - 500 CD4+ cells/mm3, and to assess the pharmacokinetics of the two drugs, given separately and in combination.

Study Overview

• Status: Completed
• Conditions: HIV Infections
• Intervention / Treatment: Drug: Zidovudine; Drug: Butyldeoxynojirimycin

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94115
      • Dr Marcus Conant
    • Tarzana, California, United States, 91356
      • Shared Med Research Foundation
  • Florida
    • Miami Beach, Florida, United States, 33140
      • Stratogen of South Florida
    • Tampa, Florida, United States, 33614
      • Saint Joseph's Hosp / Infectious Disease Rsch Institute
  • Georgia
    • Atlanta, Georgia, United States, 30327
      • West Paces Clinical Research Incoporated
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15218
      • Dr Samuel W Golden
  • Texas
    • Dallas, Texas, United States, 75216
      • Dallas Veterans Administration Med Ctr
    • Fort Worth, Texas, United States, 76104
      • Dr Daniel Barbero
    • Houston, Texas, United States, 77004
      • Park Plaza Hosp

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria

Patients must have:

• Documented HIV infection.
• CD4 cell count 200 - 500 cells/mm3.
• Prior therapy with 12 - 48 weeks of AZT.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

• Clinically significant diarrhea without definable cause (> 3 liquid stools per day for more than 7 days within 6 months prior to study entry).
• Diarrhea, as above, with known non-HIV-related cause occurring within 1 month prior to study entry.
• Symptoms meeting CDC criteria for AIDS classification.
• Fever as a constitutional sign of HIV disease (> 38.5 degrees C persisting for more than 14 consecutive days or for more than 15 days in any given 30-day period prior to study entry).
• Malignancies, other than basal cell carcinoma and Kaposi's sarcoma (provided patient has fewer than 10 Kaposi's sarcoma lesions, no non-skin lesions, and no requirement for systemic treatment).
• Significant organ dysfunction.
• Known hypersensitivity to SC-48334 or AZT or related compounds.

Concurrent Medication:

Excluded:

• Any investigational drug other than SC-48334.
• Any anti-HIV drug other than AZT.
• Cancer chemotherapy.

Patients with the following prior conditions are excluded:

• History of cataracts or known increased risk of cataract formation.
• Known hypersensitivity to SC-48334 or AZT or related compounds.
• History of lactose intolerance.

Prior Medication:

Excluded:

• Prior SC-48334.
• Cancer chemotherapy within 6 months prior to study entry.
• Treatment with any investigational drug or any drug with anti-HIV activity, other than AZT, within 30 days prior to study entry.

Prior Treatment:

Excluded:

Whole-body irradiation within 6 months prior to study entry. Current use of illicit substances, or abuse of alcohol, which would limit compliance with the protocol.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment

Collaborators and Investigators

• Sponsor: G D Searle

Publications and helpful links

General Publications

• Fischl MA, Resnick L, Coombs R, Kremer AB, Pottage JC Jr, Fass RJ, Fife KH, Powderly WG, Collier AC, Aspinall RL, et al. The safety and efficacy of combination N-butyl-deoxynojirimycin (SC-48334) and zidovudine in patients with HIV-1 infection and 200-500 CD4 cells/mm3. J Acquir Immune Defic Syndr (1988). 1994 Feb;7(2):139-47.

Study record dates

Study Major Dates

• Study Start: December 7, 2022
• Primary Completion: December 7, 2022
• Study Completion: December 7, 2022

Study Registration Dates

• First Submitted: November 2, 1999
• First Submitted That Met QC Criteria: August 30, 2001
• First Posted (Estimate): August 31, 2001

Study Record Updates

• Last Update Posted (Estimate): June 24, 2005
• Last Update Submitted That Met QC Criteria: June 23, 2005
• Last Verified: March 1, 1993

More Information

Terms related to this study

• Keywords: Zidovudine; 1-Deoxynojirimycin
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Antimetabolites; Glycoside Hydrolase Inhibitors; Zidovudine; Miglustat
• Other Study ID Numbers: 057B; NS8-91-02-009

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No