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:
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.