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Sponsored by: |
Genelabs Technologies |
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Information provided by: | NIH AIDS Clinical Trials Information Service |
ClinicalTrials.gov Identifier: | NCT00001989 |
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 |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
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:
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
Concurrent Medication:
Excluded:
Patients with the following are excluded:
Prior Medication:
Excluded:
Excluded within 30 days prior to enrollment:
Patients have the following:
Required:
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 |
Study ID Numbers: | 106A |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00001989 |
Health Authority: | United States: Food and Drug Administration |
Trichosanthin Drug Evaluation Drug Therapy, Combination Acquired Immunodeficiency Syndrome |
AIDS-Related Complex Antiviral Agents Zidovudine |
Virus Diseases Sexually Transmitted Diseases, Viral Trichosanthin HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Zidovudine AIDS-Related Complex Retroviridae Infections Immunologic Deficiency Syndromes |
Antimetabolites Anti-Infective Agents RNA Virus Infections Slow Virus Diseases Anti-HIV Agents Molecular Mechanisms of Pharmacological Action Immune System Diseases Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors Reproductive Control Agents |
Abortifacient Agents, Nonsteroidal Infection Antiviral Agents Pharmacologic Actions Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Abortifacient Agents Lentivirus Infections Antineoplastic Agents, Phytogenic Nucleic Acid Synthesis Inhibitors |