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

June 23, 2005 updated by: Genelabs Technologies
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genelabs Technologies

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

October 1, 1992

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 106A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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