ClinicalTrials.gg
CompletedNCT00002079Updated Jun 24, 2005

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)

A Phase 2 interventional study of Butyldeoxynojirimycin and Zidovudine in HIV Infections, sponsored by G D Searle. Completed at 9 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 2, Interventional, and Treatment

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Phase
Phase 2
Study type
Interventional
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.

Phase 2
478 of 2,802
7 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 one of 478 in phase 2, 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.

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02

Study summary

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.

03

Conditions studied

  • HIV Infections

Browse trials for

Keywords

  • Zidovudine
  • 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

Patients must have:

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

Exclusion criteria

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

  • 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--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).
  • , 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 to SC-48334 or AZT or related compounds.

Concurrent Medication:

Excluded:

  • Any 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.

Terms in these criteria, in plain language(6)

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.

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.

CD4 count

The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

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.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

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.

05

Study design

Phase
Phase 2
Primary purpose
Treatment

Interventions

06

Study locations

9 sites
  • Dr Marcus Conant
    San Francisco, California 94115, United States
  • Shared Med Research Foundation
    Tarzana, California 91356, United States
  • Stratogen of South Florida
    Miami Beach, Florida 33140, United States
  • Saint Joseph's Hosp / Infectious Disease Rsch Institute
    Tampa, Florida 33614, United States
  • West Paces Clinical Research Incoporated
    Atlanta, Georgia 30327, United States
  • Dr Samuel W Golden
    Pittsburgh, Pennsylvania 15218, United States
  • Dallas Veterans Administration Med Ctr
    Dallas, Texas 75216, United States
  • Dr Daniel Barbero
    Fort Worth, Texas 76104, United States
  • Park Plaza Hosp
    Houston, Texas 77004, United States
07

References and documents

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. PubMed 7905523 ↗
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
NCT00002079
Lead sponsor
G D Searle
First posted
Aug 31, 2001
Last update
Jun 24, 2005
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 1993. You cannot join it, but the record below documents what was studied.

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Discussion

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