Initial Phase II Efficacy and Safety Study of SC-48334 Administered in Combination With Low-Dose Zidovudine (AZT) to Symptomatic HIV-1 Infected Patients With = or > 200 to = or < 500 CD4+ Cells/mm3

HIV Infections Clinical Trial

Official title:

Initial Phase II Efficacy and Safety Study of SC-48334 Administered in Combination With Low-Dose Zidovudine (AZT) to Symptomatic HIV-1 Infected Patients With = or > 200 to = or < 500 CD4+ Cells/mm3

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00001993
• Other study ID #: 057A
• Secondary ID: NS8-90-02-004
• Status: Completed
• Phase: Phase 2
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: February 1992
• 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

The primary objective of this study is to determine the preliminary efficacy and tolerability of combining a selected dose of SC-48334 with low-dose AZT in the treatment of symptomatic HIV+ patients with 200 to 500 CD4+ cells/mm3.

The secondary objective is to determine the pharmacokinetics and bioavailability of both SC-48334 and AZT, when administered together, in symptomatic HIV+ patients with 200 - 500 CD4+ cells/mm3.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

Concurrent Medication:

Allowed:

• Medications for the prophylaxis of opportunistic infections, such as:

• Aerosolized pentamidine.

• Trimethoprim/sulfamethoxazole.

• Nystatin.

• Clotrimazole.

• Anti-mycobacterial agents.

• Ganciclovir.

• Topical acyclovir.

Patients must have the following:

• CD4+ cells counts = or > 200 < 500 /cell mm3.

• For purposes of inclusion the absolute CD4+ cell count must be = or > 200 < 500 cells/mm3 on the first sample and = or > 190 < 510 cells/mm3 on the second sample.

• Have at least one of the following:

• Oral candidiasis.

• Herpes zoster during the last 3 years.

• Oral hairy leukoplakia during the past three years.

• Chronic ( > 30 day period), recurrent seborrheic dermatitis, or topical, pruritic folliculitis (itchy bumps).

• Unintentional weight loss in excess of 10 pounds or 10 percent of usual body weight.

• Chronic fatigue present for the past 6 months, which has interfered with normal activity at least 1 to 2 times per week.

• HIV antibody positive as determined by federally licensed Enzyme-linked Immunosorbent Assay (ELISA).

• Documented, written informed consent must be obtained prior to admission to the study.

Prior Medication:

Allowed for no more than 12 weeks prior to study entry:

• Zidovudine (AZT).

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

• Malignancies, with the exception of basal cell carcinoma.

• Significant organ dysfunction.

Concurrent Medication:

Excluded:

• All anti-retroviral drugs with the exception of Zidovudine. Cancer chemotherapeutic agents.

• Anti-metabolites and alkylating agents.

• All investigational non-FDA approved drugs.

Patients with the following are excluded:

• Clinically significant diarrhea (> 3 liquid stools per day for > 7 days) without definable cause, within 6 months prior to enrollment).

• Diarrhea, as above, with known, non-HIV related cause occurring within one month prior to enrollment.

• Meets CDC criteria for AIDS classification.

• Chronic fever (> 38.5 C persisting for more than 14 consecutive days, or for more than 15 days in any 30-day interval prior to study entry).

• Malignancies, with the exception of basal cell carcinoma.

• Significant organ dysfunction.

• Known hypersensitivity to SC-48334 or related compounds.

• History of lactose intolerance.

Prior Medication:

Excluded within 30 days of study entry:

• Any investigational medication.

• Treatment with a drug (other than Zidovudine) with anti-HIV activity.

• Excluded for > 12 weeks prior to study entry:

• Zidovudine (AZT).

• Excluded within 90 days of study entry:

• Ribavirin.

• Excluded within 6 months of study entry:

• Cancer chemotherapy.

• Excluded:

• Treatment with SC-48334.

Prior Treatment:

Excluded within 30 days of study entry:

• Electron beam radiation.

• Excluded within 6 months prior to study entry:

• Required HIV-related blood transfusions.

• Whole body radiation.

Current use of illicit substances; or current abuse of alcohol, the use of 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	Rush Presbyterian - Saint Luke's Med Ctr	Chicago	Illinois
United States	Ohio State Univ Hosp Clinic	Columbus	Ohio
United States	Infectious Diseases Research Clinic / Indiana Univ Hosp	Indianapolis	Indiana
United States	Univ of Miami School of Medicine	Miami	Florida
United States	Univ of Washington	Seattle	Washington
United States	Julio Arroyo	West Columbia	South Carolina

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