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

Conditions: HIV Infections

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.


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 \ 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.

Keywords: drug therapy, combination zidovudine