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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)

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Butyldeoxynojirimycin
Zidovudine
Sponsored by
G D Searle
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Zidovudine, 1-Deoxynojirimycin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Dr Marcus Conant
  • Shared Med Research Foundation
  • Stratogen of South Florida
  • Saint Joseph's Hosp / Infectious Disease Rsch Institute
  • West Paces Clinical Research Incoporated
  • Dr Samuel W Golden
  • Dallas Veterans Administration Med Ctr
  • Dr Daniel Barbero
  • Park Plaza Hosp

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
G D Searle
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1. Study Identification

Unique Protocol Identification Number
NCT00002079
Brief 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)
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)
Study Type
Interventional

2. Study Status

Record Verification Date
March 1993
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
G D Searle

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Zidovudine, 1-Deoxynojirimycin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Butyldeoxynojirimycin
Intervention Type
Drug
Intervention Name(s)
Zidovudine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Dr Marcus Conant
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Shared Med Research Foundation
City
Tarzana
State/Province
California
ZIP/Postal Code
91356
Country
United States
Facility Name
Stratogen of South Florida
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
Saint Joseph's Hosp / Infectious Disease Rsch Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
West Paces Clinical Research Incoporated
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30327
Country
United States
Facility Name
Dr Samuel W Golden
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15218
Country
United States
Facility Name
Dallas Veterans Administration Med Ctr
City
Dallas
State/Province
Texas
ZIP/Postal Code
75216
Country
United States
Facility Name
Dr Daniel Barbero
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Park Plaza Hosp
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
7905523
Citation
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.
Results Reference
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Learn more about this trial

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)

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