A Randomized Phase II Efficacy, Activity and Safety Study of GLQ223 Alone and in Combination With Zidovudine in Symptomatic HIV-Infected Patients Without Prior Treatment With GLQ223 or Trichosanthin

Launched by GENELABS TECHNOLOGIES · Aug 30, 2001

Keywords

ClinConnect Summary

The study will involve the randomization of patients with 200-500 T4 cells and AIDS or ARC to one of three treatment arms: zidovudine alone, GLQ223 alone, or GLQ223 plus zidovudine. Patients randomized to receive GLQ223 will receive an infusion every three weeks for 45 weeks.

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• Concurrent Medication:
• Allowed:
• • Aerosolized pentamidine, trimethoprim/sulfamethoxazole, or dapsone for PCP prophylaxis.
• * Chronic suppressive therapy for the following infections:
• • Toxoplasmosis (pyrimethamine, sulfadiazine, or clindamycin). Cryptococcosis (fluconazole). Candidiasis (ketoconazole). Herpes simplex virus (acyclovir). Mycobacterium avium (isoniazid, clofazimine, amikacin, rifampin, rifabutin, ethambutol, or other drug with written permission of the sponsor).
• Required:
• • Patients whose CD4+ count falls below 200 at two consecutive measurements must receive prophylaxis for PCP and any other clinically indicated conditions.
• • Exclusion Criteria
• Co-existing Condition:
• Patients with the following conditions or symptoms are excluded:
• • An active AIDS-defining opportunistic infection.
• • Evidence of AIDS dementia complex or active neurologic disease, including progressive multi-focal leukoencephalopathy (PML), poorly controlled seizure disorder or active CNS infection.
• • Any condition which in the Investigator's opinion is sufficient to prevent adequate compliance with the study.
• Concurrent Medication:
• Excluded:
• • Therapeutic agents specific for HIV disease that have not received FDA approval.
• • Biologic response modifiers, including interferon, interleukin-2 (IL-2), and leukocyte stimulating hormones (GM-CSF, G-CSF).
• Patients with the following are excluded:
• • An active AIDS-defining opportunistic infection.
• • Evidence of AIDS dementia complex or active neurologic disease, including progressive multi-focal leukoencephalopathy (PML), poorly controlled seizure disorder or active CNS infection.
• • Participation in other clinical studies, including investigational therapy of HIV infection.
• • Any condition which in the Investigator's opinion is sufficient to prevent adequate compliance with the study.
• • History of prior use of GLQ223 or trichosanthin or presence of anti-GLQ223 serum IgG antibody as measured by Western blot.
• • Inability to provide written informed consent.
• Prior Medication:
• Excluded:
• • History of prior use of GLQ223 or trichosanthin or presence of anti-GLQ serum IgG antibody as measured by Western blot.
• Excluded within 30 days prior to enrollment:
• • Use of unapproved therapeutic agents specific for HIV disease, including ddC.
• • Use of biologic response modifiers, including interferon, interleukin-2, and leukocyte stimulating hormones (GM-CSF, G-CSF).
• Patients have the following:
• • HIV positive by ELISA with confirmation by Western blot.
• • Symptomatic with AIDS-Related Complex or AIDS by CDC classification.
• • History of zidovudine therapy at a dose equal to or more than 300 mg daily for at least 9 consecutive months immediately prior to entry into study.
• • CD4 count equal to or more than 200 and equal to or less than 500 (mean of 2 readings one week apart).
• • Ability to give informed consent.
• Required:
• • Zidovudine therapy at a dose equal to or more than 300 mg daily for at least 9 months immediately prior to entry into the study.