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| 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 |
Eligibility| 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:
Contacts and 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 | |
More Information
| 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 |
|
Trichosanthin Drug Evaluation Drug Therapy, Combination Acquired Immunodeficiency Syndrome |
AIDS-Related Complex Antiviral Agents Zidovudine |
|
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 |