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

The Searle Company

Status and phase: Completed; Phase 2

Conditions: HIV Infections

Treatments: Drug: Zidovudine; Drug: Butyldeoxynojirimycin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00001993

NS8-90-02-004

057A

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.