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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: | Allocation: Randomized Endpoint Classification: Safety Study Primary Purpose: Treatment |
| 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
| ClinicalTrials.gov Identifier: | NCT00001989 History of Changes |
| Other Study ID Numbers: | 106A |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Food and Drug Administration |
|
Trichosanthin Drug Evaluation Drug Therapy, Combination Acquired Immunodeficiency Syndrome |
AIDS-Related Complex Antiviral Agents Zidovudine |
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Trichosanthin Zidovudine Antineoplastic Agents, Phytogenic Antineoplastic Agents |
Therapeutic Uses Pharmacologic Actions Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents Physiological Effects of Drugs Antimetabolites Molecular Mechanisms of Pharmacological Action Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors |