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

Completed · Phase 2

Conditions studied: HIV Infections

In brief

This study involves GLQ223 administration to patients who have not previously been exposed to it, but who have received at least 9 months of zidovudine therapy. Efficacy evaluations will include survival, opportunistic infections, T4 cell count, and assessments of viral load.

Key facts

Study ID

NCT00001989

Run by

Genelabs Technologies

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• ViRx Inc — San Francisco, California, United States
• Dr Larry A Waites — San Francisco, California, United States
• Saint Francis Mem Hosp — San Francisco, California, United States
• UCSF - San Francisco Gen Hosp — San Francisco, California, United States
• Miami Veterans Administration Med Ctr — Miami, Florida, United States
• Infectious Disease Research Institute Inc — Tampa, Florida, United States
• Northwestern Univ — Chicago, Illinois, United States
• Saint Vincent's Hosp and Med Ctr — New York, New York, United States

Full record on ClinicalTrials.gov

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