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

NCT ID: NCT00001993

Last Updated: 2005-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL

Brief 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.

Conditions

HIV Infections

Study Design

• Primary Study Purpose: TREATMENT

Interventions

Butyldeoxynojirimycin

Intervention Type: DRUG

Zidovudine

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

G D Searle

INDUSTRY

Sponsor Role: lead

Locations

Univ of Miami School of Medicine

Miami, Florida, United States

Rush Presbyterian - Saint Luke's Med Ctr

Chicago, Illinois, United States

Infectious Diseases Research Clinic / Indiana Univ Hosp

Indianapolis, Indiana, United States

Ohio State Univ Hosp Clinic

Columbus, Ohio, United States

Julio Arroyo

West Columbia, South Carolina, United States

Univ of Washington

Seattle, Washington, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 7905523 (View on PubMed)

Other Identifiers

NS8-90-02-004

Identifier Type: -

Identifier Source: secondary_id

057A

Identifier Type: -

Identifier Source: org_study_id