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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 Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on 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 conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. 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 research trials and 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 medical trials happen in hundreds of localities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like 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. 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 and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a 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 trial. Participants frequently obtain the most expert healthcare available for their 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 condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials 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  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
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
For Condition: HIV Infections
Status: Completed
Sponsor(s): Genelabs Technologies ,
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment, Randomized, Safety Study
Minimum Age/Maximum Age: 18 Years/65 Years
Genders: Both
Protocol Entry Criteria: 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, ethambutal, 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: - 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. - Inability to provide written informed consent. Prior Medication: Excluded: - History of prior use of GLQ223 or trichosanthin or presence of anti-GLQ serum IgG antibody as measured by Western blot. Excluded within 30 days prior to enrollment: - Use of unapproved therapeutic agents specific for HIV disease, including ddC. - Use of biologic response modifiers, including interferon, interleukin-2, and leukocyte stimulating hormones (GM-CSF, G-CSF). Patients have the following: - HIV positive by ELISA with confirmation by Western blot. - Symptomatic with AIDS-Related Complex or AIDS by CDC classification. - History of zidovudine therapy at a dose equal to or more than 300 mg daily for at least 9 consecutive months immediately prior to entry into study. - CD4 count equal to or more than 200 and equal to or less than 500 (mean of 2 readings one week apart). - Ability to give informed consent. Required: - Zidovudine therapy at a dose equal to or more than 300 mg daily for at least 9 months immediately prior to entry into the study.
Total Enrollment:
Location and Contact Information:
Northwestern Univ
Chicago, Illinois, 60611
United States
UCSF - San Francisco Gen Hosp
San Francisco, California, 94110
United States
ViRx Inc
San Francisco, California, 94103
United States
Dr Larry A Waites
San Francisco, California, 94108
United States
Saint Francis Mem Hosp
San Francisco, California, 94109
United States
Miami Veterans Administration Med Ctr
Miami, Florida, 33125
United States
Saint Vincent's Hosp and Med Ctr
New York City, New York, 10011
United States
Infectious Disease Research Institute Inc
Tampa, Florida, 33614
United States
Additional Information:
Study ID Numbers: 106A;
Study Start Date:
Record last reviewed: October 1992
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001989
Other Hiv Infections Studies:
1. Phase II Randomized Open-Label Trial of Atovaquone Plus Pyrimethamine and Atovaquone Plus Sulfadiazine for the Treatment of Acute Toxoplasmic Encephalitis
2. The Antiviral Efficacy of Concurrent Zidovudine and 2',3'-dideoxyinosine or 2',3'-dideoxycytidine in Patients with Human Immunodeficiency Virus Disease
3. A Study to Compare Two Anti-HIV Combination Therapies Each Containing Saquinavir in HIV-Positive Children
4. A Randomized, Controlled Study of Intravenous Ganciclovir Therapy for Peripheral Cytomegalovirus Retinitis in Patients With AIDS
5. A Phase I Study of Recombinant Human CD4 Immunoglobulin G (rCD4-lgG) in Patients with HIV-Associated Immune Thrombocytopenic Purpura
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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
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