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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.
First Received: November 2, 1999   Last Updated: June 23, 2005   History of Changes
Sponsor: Genelabs Technologies
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00001989
  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 II

Study Type: Interventional
Study Design: Treatment, Randomized, Safety Study
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
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:
Byers VS, Levin AS, Malvino A, Waites L, Robins RA, Baldwin RW. A phase II study of effect of addition of trichosanthin to zidovudine in patients with HIV disease and failing antiretroviral agents. AIDS Res Hum Retroviruses. 1994 Apr;10(4):413-20.
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

Study ID Numbers: 106A
Study First Received: November 2, 1999
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00001989     History of Changes
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:
Antimetabolites
Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Trichosanthin
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Zidovudine
Reproductive Control Agents
Infection
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Abortifacient Agents
Retroviridae Infections
Nucleic Acid Synthesis Inhibitors
RNA Virus Infections
Anti-HIV Agents
Immune System Diseases
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Abortifacient Agents, Nonsteroidal
Antiviral Agents
Immunologic Deficiency Syndromes
Pharmacologic Actions
Virus Diseases
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections

ClinicalTrials.gov processed this record on November 05, 2009