HIV Infections
Conditions
Keywords
Drug Therapy, Combination, Zidovudine
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.
Interventions
DRUGZidovudine
Sponsors
G D Searle
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Countries
United States
Outcome results
None listed