ClinicalTrials.gg
CompletedNCT00000692Updated Jun 24, 2005

Phase I Rising Dose Tolerability Study of SC-48334 in Patients With Acquired Immunodeficiency Syndrome (AIDS) and Advanced AIDS Related Complex

A Phase 1 interventional study of Butyldeoxynojirimycin in HIV Infections, sponsored by G D Searle. Completed at 6 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2005-06-24.

Sponsored by G D Searle · Phase 1, Interventional, and Treatment

Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →

Phase
Phase 1
Study type
Interventional
Enrollment
48
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 2,802 studies in HIV Infections with a site in United States — 83 open to participants now, 140 under way, 11 of them phase 3. HIV Infections · United States.

Enrollment
1,264th of 2,150
48 · median 60
Phase 1
671 of 2,802
10 open now
Registered
4th of 2,802
by date

Among the 2,802 studies in HIV Infections with a site in United States, this one is the 1,264th largest by enrollment of the 2,150 interventional ones that give a count, is one of 671 in phase 1, and was the 4th registered.

HIV Infections

4,736 studies on the registry are indexed under HIV Infections; 246 are open to participants now.

Browse HIV Infections studies →

Open to participants now

83 of the 2,802 studies in HIV Infections with a site in United States are open now. Recruiting first, the newest first:

78 more — sign in →

All 83 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 159 HIV Infections studies recruiting now, 104 (65%) set no upper age limit and 42 (26%) stop at 75 or younger; 31 take children under 18; 60 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 2,802 studies in HIV Infections with a site in United States, or all of them as a file.
02

Study summary

To determine the following about the use of SC-48334 in patients with AIDS and advanced AIDS related complex (ARC):

  1. The largest maximum tolerated dose (MTD); 2. Effectiveness against HIV; 3. Pharmacokinetics - how fast SC-48334 reaches the bloodstream, what concentration is reached, and how long it remains in the patient's blood.

SC-48334 is a chemical that prevents the biochemical actions of certain enzymes in the body, and recent studies have shown that it may also prevent the activity of HIV. The study will attempt to show whether SC-48334 can safely and effectively break the cycle of HIV infection in AIDS and advanced ARC by progressively eliminating HIV.

Read the detailed description

SC-48334 is a chemical that prevents the biochemical actions of certain enzymes in the body, and recent studies have shown that it may also prevent the activity of HIV. The study will attempt to show whether SC-48334 can safely and effectively break the cycle of HIV infection in AIDS and advanced ARC by progressively eliminating HIV.

Six patients are enrolled sequentially into each of eight different dose levels and the drug is administered by mouth at least 60 minutes before meals according to the following schedule: Day 1: One-quarter of total assigned daily dose. Patients receive the dosage in the hospital as either an inpatient or outpatient and are observed for 12 hours, during which time they are evaluated and blood is drawn for pharmacokinetic studies. Patients return at 24 and 48 hours for a limited physical examination and additional pharmacokinetic studies. Days 4 - 31: Total assigned daily dose, one-quarter 4 times a day. Patients are observed for at least 5 days in the hospital following the start of this part of the program, during which time clinical, laboratory, and pharmacokinetic information is obtained in order to establish baseline values. After the 6th day, patients are evaluated with a complete physical exam, urinalysis, and laboratory studies once a week and a limited physical exam and brief laboratory studies 3 times a week. At each of the eight dose levels, the second and third patients receive their first dose only after the first patient has been followed for 72 hours after receiving the first dose. Patients 4, 5, and 6 begin treatment only after patients 2 and 3 have completed 14 days of the four-part total dose. Patients are treated on an outpatient basis, with 5 to 6 days spent in the hospital for evaluation.

03

Conditions studied

  • HIV Infections

Keywords

  • Acquired Immunodeficiency Syndrome
  • AIDS-Related Complex
  • Antiviral Agents
  • Biological Availability
  • 1-Deoxynojirimycin
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Concurrent Medication:

Allowed:

  • Aerosolized pentamidine.
  • Nystatin.
  • Clotrimazole.
  • Topical acyclovir.

Concurrent Treatment:

Allowed:

  • Blood transfusions for = or > grade 3 toxicity.

Exclusion criteria

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions will be excluded:

  • Clinical significant diarrhea (> 3 stools per day for > 7 days without definable cause).
  • Active opportunistic infection, requiring ongoing therapy, at time of enrollment.
  • Any besides Kaposi's sarcoma, basal cell carcinoma, or squamous cell carcinoma unless the squamous cell carcinoma requires ongoing therapy.
  • Neurologic disease including dementia, peripheral neuropathy, myelopathy (CDC category IVb).

Concurrent Medication:

Excluded:

  • Antimetabolites.
  • Alkylating agents.
  • Drugs with known hepatic or bone marrow toxicity.

Patients with significant organ dysfunction will be excluded.

Prior Medication:

Excluded:

  • Antimetabolites.
  • Alkylating agents.
  • Excluded within 30 days of study entry:
  • Any medication.
  • Drugs with anti- activity.
  • Excluded within 90 days of study entry:
  • Ribavirin treatment.
  • Excluded within 6 months of study entry:
  • Cancer chemotherapy.

Prior Treatment:

Excluded within 6 months of study entry:

  • Radiation therapy.

Patients must demonstrate the following clinical and laboratory findings:

  • AIDS or advanced AIDS related complex (ARC), according to Centers for Disease Control (CDC) category IV, excluding neurologic disease in IVb.
  • Ability to understand the terms of study participation.

Current use of illicit drugs or abuse of alcohol.

Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Masking
None (open label)
Enrollment
48 participants

Interventions

06

Study locations

6 sites
  • Univ of California / San Diego Treatment Ctr
    San Diego, California 921036325, United States
  • Stanford Univ School of Medicine
    Stanford, California 94305, United States
  • Univ of Miami School of Medicine
    Miami, Florida 331361013, United States
  • Rush Presbyterian - Saint Luke's Med Ctr
    Chicago, Illinois 60612, United States
  • Harvard (Massachusetts Gen Hosp)
    Boston, Massachusetts 02114, United States
  • Julio Arroyo
    West Columbia, South Carolina 29169, United States
07

References and documents

Publications

  • Tierney M, Pottage J, Kessler H, Fischl M, Richman D, Merigan T, Powderly W, Smith S, Karim A, Sherman J, et al. The tolerability and pharmacokinetics of N-butyl-deoxynojirimycin in patients with advanced HIV disease (ACTG 100). The AIDS Clinical Trials Group (ACTG) of the National Institute of Allergy and Infectious Diseases. J Acquir Immune Defic Syndr Hum Retrovirol. 1995 Dec 15;10(5):549-53. PubMed 8548334 ↗
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2005, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00000692
Lead sponsor
G D Searle
First posted
Aug 31, 2001
Last update
Jun 24, 2005

Study contacts

MS Hirsch
study chair
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2003. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Miglustat

Start the discussion