Initial Phase II Efficacy and Safety Study of SC-48334 Administered in Combination With Low-Dose Zidovudine (AZT) to Symptomatic HIV-1 Infected Patients With = or > 200 to = or < 500 CD4+ Cells/mm3

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00001993
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: February 1992
  Purpose

The primary objective of this study is to determine the preliminary efficacy and tolerability of combining a selected dose of SC-48334 with low-dose AZT in the treatment of symptomatic HIV+ patients with 200 to 500 CD4+ cells/mm3.

The secondary objective is to determine the pharmacokinetics and bioavailability of both SC-48334 and AZT, when administered together, in symptomatic HIV+ patients with 200 - 500 CD4+ cells/mm3.


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: Initial Phase II Efficacy and Safety Study of SC-48334 Administered in Combination With Low-Dose Zidovudine (AZT) to Symptomatic HIV-1 Infected Patients With = or > 200 to = or < 500 CD4+ Cells/mm3

Resource links provided by NLM:


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

Estimated Enrollment: 120
  Eligibility

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

Inclusion Criteria

Concurrent Medication:

Allowed:

  • Medications for the prophylaxis of opportunistic infections, such as:
  • Aerosolized pentamidine.
  • Trimethoprim/sulfamethoxazole.
  • Nystatin.
  • Clotrimazole.
  • Anti-mycobacterial agents.
  • Ganciclovir.
  • Topical acyclovir.

Patients must have the following:

  • CD4+ cells counts = or > 200 < 500 /cell mm3.
  • For purposes of inclusion the absolute CD4+ cell count must be = or > 200 < 500 cells/mm3 on the first sample and = or > 190 < 510 cells/mm3 on the second sample.
  • Have at least one of the following:
  • Oral candidiasis.
  • Herpes zoster during the last 3 years.
  • Oral hairy leukoplakia during the past three years.
  • Chronic ( > 30 day period), recurrent seborrheic dermatitis, or topical, pruritic folliculitis (itchy bumps).
  • Unintentional weight loss in excess of 10 pounds or 10 percent of usual body weight.
  • Chronic fatigue present for the past 6 months, which has interfered with normal activity at least 1 to 2 times per week.
  • HIV antibody positive as determined by federally licensed Enzyme-linked Immunosorbent Assay (ELISA).
  • Documented, written informed consent must be obtained prior to admission to the study.

Prior Medication:

Allowed for no more than 12 weeks prior to study entry:

  • Zidovudine (AZT).

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

  • Malignancies, with the exception of basal cell carcinoma.
  • Significant organ dysfunction.

Concurrent Medication:

Excluded:

  • All anti-retroviral drugs with the exception of Zidovudine. Cancer chemotherapeutic agents.
  • Anti-metabolites and alkylating agents.
  • All investigational non-FDA approved drugs.

Patients with the following are excluded:

  • Clinically significant diarrhea (> 3 liquid stools per day for > 7 days) without definable cause, within 6 months prior to enrollment).
  • Diarrhea, as above, with known, non-HIV related cause occurring within one month prior to enrollment.
  • Meets CDC criteria for AIDS classification.
  • Chronic fever (> 38.5 C persisting for more than 14 consecutive days, or for more than 15 days in any 30-day interval prior to study entry).
  • Malignancies, with the exception of basal cell carcinoma.
  • Significant organ dysfunction.
  • Known hypersensitivity to SC-48334 or related compounds.
  • History of lactose intolerance.

Prior Medication:

Excluded within 30 days of study entry:

  • Any investigational medication.
  • Treatment with a drug (other than Zidovudine) with anti-HIV activity.
  • Excluded for > 12 weeks prior to study entry:
  • Zidovudine (AZT).
  • Excluded within 90 days of study entry:
  • Ribavirin.
  • Excluded within 6 months of study entry:
  • Cancer chemotherapy.
  • Excluded:
  • Treatment with SC-48334.

Prior Treatment:

Excluded within 30 days of study entry:

  • Electron beam radiation.
  • Excluded within 6 months prior to study entry:
  • Required HIV-related blood transfusions.
  • Whole body radiation.

Current use of illicit substances; or current abuse of alcohol, the use of 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: NCT00001993

Locations
United States, Florida
Univ of Miami School of Medicine
Miami, Florida, United States, 331361013
United States, Illinois
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, United States, 60612
United States, Indiana
Infectious Diseases Research Clinic / Indiana Univ Hosp
Indianapolis, Indiana, United States, 46202
United States, Ohio
Ohio State Univ Hosp Clinic
Columbus, Ohio, United States, 432101228
United States, South Carolina
Julio Arroyo
West Columbia, South Carolina, United States, 29169
United States, Washington
Univ of Washington
Seattle, Washington, United States, 981224304
Sponsors and Collaborators
G D Searle
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00001993     History of Changes
Other Study ID Numbers: 057A, NS8-90-02-004
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:
Drug Therapy, Combination
Zidovudine

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 July 26, 2014