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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 | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

NCT00001989•Genelabs Technologies

View on ClinicalTrials.gov

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.

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

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

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:
+20 more criteria

Locations (8)

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

Key Dates

Last Updated

June 24, 2005

Conditions

HIV Infections

Interventions

Trichosanthin

DRUG

Zidovudine

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 24, 2005Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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