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A Study of Thymic Humoral Factor (THF gamma 2) in HIV-Infected Patients Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on A Study of Thymic Humoral Factor (THF gamma 2) in HIV-Infected Patients conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. A Study of Thymic Humoral Factor (THF gamma 2) in HIV-Infected Patients Clinical research trials and A Study of Thymic Humoral Factor (THF gamma 2) in HIV-Infected Patients health trials occur in hundreds of cities 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 assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including A Study of Thymic Humoral Factor (THF gamma 2) in HIV-Infected Patients. A Study of Thymic Humoral Factor (THF gamma 2) in HIV-Infected Patients Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a A Study of Thymic Humoral Factor (THF gamma 2) in HIV-Infected Patients clinical trial. Participants oftentimes recieve the most expert healthcare available for their A Study of Thymic Humoral Factor (THF gamma 2) in HIV-Infected Patients condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A Study of Thymic Humoral Factor (THF gamma 2) in HIV-Infected Patients  A Study of Thymic Humoral Factor (THF gamma 2) in HIV-Infected Patients
A Study of Thymic Humoral Factor (THF gamma 2) in HIV-Infected Patients
For Condition: HIV Infections
Status: Completed
Sponsor(s): Pharmacia ,
Synopsis: To investigate the safety of thymic humoral factor (THF gamma 2), its effect on HIV load based on at least a 75 percent decrease in HIV quantitative PCR RNA copies/ml, and its persistence when administered in combination with an antiretroviral nucleoside derivative (zidovudine; AZT). To assess the effects of THF gamma 2 on T-cells, quality of life, and progression of disease.
Details: All patients receive 12 weeks of AZT before being randomized to self-administer one of two doses of THF gamma 2 or placebo for 15 consecutive days and then twice weekly for an additional 50 weeks.
Eligibility:
Study Type: Interventional, Treatment, Double-Blind, Safety Study
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - AZT or another antiretroviral agent (marketed or investigational under a Treatment IND). - Primary prophylaxis for Pneumocystis carinii pneumonia (PCP), toxoplasmosis, and Mycobacterium avium-intracellulare (MAI) if patient's CD4 count decreases to < 200 cells/mm3. - Other marketed drugs as required. Patients must have: - HIV seropositivity and be either asymptomatic or have persistent generalized lymphadenopathy (PGL). - No history of symptoms in Category B or C of 1993 Case Definition, other than oral candidiasis following previous broad-spectrum antibiotic therapy. - Mean CD4 of 200-500 cells/mm3. - HIV-1 positive PCR RNA. - Ability to self-administer study drug by IM injection. - Ability to tolerate AZT at 600 mg daily during first 8 weeks of run-in period (if AZT naive) OR tolerated AZT at >= 500 mg daily for at least 3 months but no more than 12 months prior to randomization. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: - Malignancy. - Hematuria. - Proteinuria > 1+. Concurrent Medication: Excluded: - Non-antiretroviral agents with known or suspected activity against HIV. - Investigational new drugs that are not antiretroviral agents distributed under a Treatment IND. Patients with the following prior conditions are excluded: Myositis within the past 6 months. Prior Medication: Excluded: - Experimental therapy, including interleukin-2, interferon, erythropoietin, or filgrastim nucleoside within 6 weeks prior to study entry. - Prior antiretroviral therapy (AZT-naive patients only). Prior Treatment: Excluded within 6 weeks prior to study entry: - Blood transfusion or blood products. Active alcoholism, drug abuse, or a mental or psychiatric problem sufficient to prevent adequate compliance with study.
Total Enrollment:
Location and Contact Information:
Dr Alfred F Burnside Jr
Columbia, South Carolina, 29204
United States
Portland Veterans Adm Med Ctr / Rsch & Education Grp
Portland, Oregon, 97210
United States
Southwest Community Based AIDS Treatment Group - COMBAT
Los Angeles, California, 90028
United States
Gottlieb Med Group
Sherman Oaks, California, 91403
United States
San Francisco Veterans Administration Med Ctr
San Francisco, California, 94121
United States
Chelsea Village Med Ctr
New York City, New York, 10014
United States
Mem Hosp Hollywood
Hollywood, Florida, 33021
United States
UCI
Irvine, California, 92717
United States
Infectious Disease Physicians Inc
Annandale, Virginia, 22203
United States
Goodgame Med Group
Maitland, Florida, 32751
United States
Additional Information:
Study ID Numbers: 136A; CS 112010-999
Study Start Date:
Record last reviewed: February 1998
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002435
Other Hiv Infections Studies:
1. Prevalence of Hepatitis C Virus Infection in HIV-Infected Children
2. Carotid Artery Thickness in HIV Infected and Uninfected Adults
3. The Effect of Efavirenz and Nelfinavir on the Blood Levels of Certain Lipid-Lowering Drugs
4. Safety of and Immune System Response to an HIV Vaccine (EP-HIV-1090) in HIV Infected Patients
5. 4-Day-A-Week Treatment Plan for HIV Infected Adolescents
Related Studies:
Other HIV Infections Clinical Trials
Other Oregon Clinical Trials
Other Portland Clinical Trials
A Study of Thymic Humoral Factor (THF gamma 2) in HIV-Infected Patients
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