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)

HIV Infections Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002079
• Other study ID #: 057B
• Secondary ID: NS8-91-02-009
• Status: Completed
• Phase: Phase 2
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: March 1993
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Pharmacokinetics Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Butyldeoxynojirimycin

• Zidovudine

Locations

Country	Name	City	State
United States	West Paces Clinical Research Incoporated	Atlanta	Georgia
United States	Dallas Veterans Administration Med Ctr	Dallas	Texas
United States	Dr Daniel Barbero	Fort Worth	Texas
United States	Park Plaza Hosp	Houston	Texas
United States	Stratogen of South Florida	Miami Beach	Florida
United States	Dr Samuel W Golden	Pittsburgh	Pennsylvania
United States	Dr Marcus Conant	San Francisco	California
United States	Saint Joseph's Hosp / Infectious Disease Rsch Institute	Tampa	Florida
United States	Shared Med Research Foundation	Tarzana	California

Sponsors (1)

Lead Sponsor	Collaborator
G D Searle

Country where clinical trial is conducted

United States, 

References & 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. 1994 Feb;7(2):139-47. — View Citation