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)

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002079
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: March 1993

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00002079 on ClinicalTrials.gov Archive Site
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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)
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)

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.

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Interventional
Phase 2
Endpoint Classification: Pharmacokinetics Study
Primary Purpose: Treatment
HIV Infections
  • Drug: Butyldeoxynojirimycin
  • Drug: Zidovudine
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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. 1994 Feb;7(2):139-47.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002079
057B, NS8-91-02-009
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G D Searle
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NIH AIDS Clinical Trials Information Service
March 1993

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP