NCT00001993

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_2 hiv-infections

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

June 24, 2005

Status Verified

February 1, 1992

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

HIV Infections

Keywords

Drug Therapy, CombinationZidovudine

Interventions

ButyldeoxynojirimycinDRUG
ZidovudineDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • Have at least one of the following:
  • Oral candidiasis.
  • Herpes zoster during the last 3 years.
  • +9 more criteria

You may not qualify if:

  • 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.
  • +22 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Univ of Miami School of Medicine

Miami, Florida, 331361013, United States

Location

Rush Presbyterian - Saint Luke's Med Ctr

Chicago, Illinois, 60612, United States

Location

Infectious Diseases Research Clinic / Indiana Univ Hosp

Indianapolis, Indiana, 46202, United States

Location

Ohio State Univ Hosp Clinic

Columbus, Ohio, 432101228, United States

Location

Julio Arroyo

West Columbia, South Carolina, 29169, United States

Location

Univ of Washington

Seattle, Washington, 981224304, United States

Location

Related Publications (1)

  • 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.

    PMID: 7905523BACKGROUND

MeSH Terms

Conditions

HIV Infections

Interventions

miglustatZidovudine

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

ThymidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDideoxynucleosidesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Last Updated

June 24, 2005

Record last verified: 1992-02

Locations

US(6)