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)

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002079
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: March 1993
  Purpose

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.


Condition Intervention Phase
HIV Infections
Drug: Butyldeoxynojirimycin
Drug: Zidovudine
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002079

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

Publications:
ClinicalTrials.gov Identifier: NCT00002079     History of Changes
Other Study ID Numbers: 057B, NS8-91-02-009
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Zidovudine
1-Deoxynojirimycin

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Zidovudine
Miglustat
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on August 21, 2014