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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00001989
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: October 1992
  Purpose

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.


Condition Intervention Phase
HIV Infections
Drug: Trichosanthin
Drug: Zidovudine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001989

Locations
United States, California
Saint Francis Mem Hosp
San Francisco, California, United States, 94109
ViRx Inc
San Francisco, California, United States, 94103
UCSF - San Francisco Gen Hosp
San Francisco, California, United States, 94110
Dr Larry A Waites
San Francisco, California, United States, 94108
United States, Florida
Miami Veterans Administration Med Ctr
Miami, Florida, United States, 33125
Infectious Disease Research Institute Inc
Tampa, Florida, United States, 33614
United States, Illinois
Northwestern Univ
Chicago, Illinois, United States, 60611
United States, New York
Saint Vincent's Hosp and Med Ctr
New York, New York, United States, 10011
Sponsors and Collaborators
Genelabs Technologies
  More Information

Publications:
Waites AL, Klimas N, Yangco B, Chew T, Lang W, Von Roenn J, Torres G, Gorelick KJ, Kahn JO. Final report of a randomized phase II study of GLQ223 in AIDS and ARC. Program Abstr Intersci Conf Antimicrob Agents Chemother. 1994 Oct 4-7:61

ClinicalTrials.gov Identifier: NCT00001989     History of Changes
Other Study ID Numbers: 106A
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Trichosanthin
Drug Evaluation
Drug Therapy, Combination
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Antiviral Agents
Zidovudine

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Trichosanthin
Zidovudine
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 23, 2014