NCT00001989

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

June 24, 2005

Status Verified

October 1, 1992

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

HIV Infections

Keywords

TrichosanthinDrug EvaluationDrug Therapy, CombinationAcquired Immunodeficiency SyndromeAIDS-Related ComplexAntiviral AgentsZidovudine

Interventions

TrichosanthinDRUG
ZidovudineDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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.
  • +15 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

ViRx Inc

San Francisco, California, 94103, United States

Location

Dr Larry A Waites

San Francisco, California, 94108, United States

Location

Saint Francis Mem Hosp

San Francisco, California, 94109, United States

Location

UCSF - San Francisco Gen Hosp

San Francisco, California, 94110, United States

Location

Miami Veterans Administration Med Ctr

Miami, Florida, 33125, United States

Location

Infectious Disease Research Institute Inc

Tampa, Florida, 33614, United States

Location

Northwestern Univ

Chicago, Illinois, 60611, United States

Location

Saint Vincent's Hosp and Med Ctr

New York, New York, 10011, United States

Location

Related Publications (2)

  • 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. doi: 10.1089/aid.1994.10.413.

    PMID: 7915124BACKGROUND

  • 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

    BACKGROUND

MeSH Terms

Conditions

HIV InfectionsAcquired Immunodeficiency SyndromeAIDS-Related Complex

Interventions

TrichosanthinZidovudine

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus Diseases

Intervention Hierarchy (Ancestors)

Ribosome Inactivating Proteins, Type 1Ribosome Inactivating ProteinsPlant ProteinsProteinsAmino Acids, Peptides, and ProteinsThymidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDideoxynucleosidesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Last Updated

June 24, 2005

Record last verified: 1992-10

Locations

US(8)