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A Study of AL721 in HIV-Infected Patients with Swollen Lymph Nodes Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about A Study of AL721 in HIV-Infected Patients with Swollen Lymph Nodes conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. A Study of AL721 in HIV-Infected Patients with Swollen Lymph Nodes Clinical research trials and A Study of AL721 in HIV-Infected Patients with Swollen Lymph Nodes healthcare trials happen in many of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as A Study of AL721 in HIV-Infected Patients with Swollen Lymph Nodes. A Study of AL721 in HIV-Infected Patients with Swollen Lymph Nodes Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a A Study of AL721 in HIV-Infected Patients with Swollen Lymph Nodes clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their A Study of AL721 in HIV-Infected Patients with Swollen Lymph Nodes condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > A Study of AL721 in HIV-Infected Patients with Swollen Lymph Nodes  A Study of AL721 in HIV-Infected Patients with Swollen Lymph Nodes
A Study of AL721 in HIV-Infected Patients with Swollen Lymph Nodes
For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: To study the tolerance and safety of increasing doses of AL-721 in patients with persistent generalized lymphadenopathy (PGL) and symptomatic HIV infection, and to obtain preliminary information on the effectiveness of AL-721 against the human immunodeficiency virus (HIV) in HIV-infected persons with PGL and symptomatic HIV infection. Although zidovudine (AZT) prolongs life in certain AIDS patients, it is not a cure for AIDS and it also has toxic effects in many patients. Therefore, it is necessary to test other drugs in HIV-infected patients. AL-721 is a mixture of lipids (fats) extracted from egg yolks. Laboratory tests suggest that it might inhibit the infectivity of the HIV. AL-721 has been tried so far in a few patients for short periods of time and has been found to be well tolerated.
Details: Although zidovudine (AZT) prolongs life in certain AIDS patients, it is not a cure for AIDS and it also has toxic effects in many patients. Therefore, it is necessary to test other drugs in HIV-infected patients. AL-721 is a mixture of lipids (fats) extracted from egg yolks. Laboratory tests suggest that it might inhibit the infectivity of the HIV. AL-721 has been tried so far in a few patients for short periods of time and has been found to be well tolerated. Patients receive AL-721 twice daily. The first dose is taken on an empty stomach 1 hour before a fat-free breakfast, with specific instructions given on foods that are allowed; the second dose is taken at least 3 hours after the evening meal. No snacks are permitted after the evening meal or after the evening dose of study medication. The study is scheduled to last for 16 weeks of treatment and 4 weeks of follow-up. Throughout the study, frequent blood samples will be taken from an arm vein. The blood samples are studied to evaluate any changes in the patient's immune system, any toxic effects that might be detected in the blood, and any changes in the presence of the HIV in the blood.
Eligibility:
Study Type: Interventional, Treatment, Open Label
Minimum Age/Maximum Age: 18 Years/60 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria - Persistent generalized lymphadenopathy (PGL) (CDC-Group III), defined as palpable lymphadenopathy (nodes of 1 cm or greater) at two or more noncontiguous extrainguinal sites persisting for > 3 months in the absence of an illness other than HIV infection to account for the findings. - AIDS related complex (ARC), defined as the presence of at least one of the following findings within 12 months prior to entry and the absence of a concurrent illness or condition other than HIV infection to explain the findings: - Any findings which define CDC-Group IV A. - History of any one of the findings that define CDC-Group IV C2. - Patients with any of the ARC symptoms can also have PGL and be enrolled in the protocol as ARC patients. - A positive antibody to HIV by any federally licensed ELISA test kit within 30 days of entry. Concurrent Medication: Allowed: - Topical or oral antifungal, antiviral, or antibiotic agents to treat oral candidiasis, herpes simplex, herpes zoster, or bacterial infections that develop during the course of the study. Exclusion Criteria - Exclude hemophiliacs. - Active substance abuse. - Alcohol consumption should be kept to a minimum. Co-existing Condition: Patients with the following will be excluded: - Hemophilia. - History or presence of an AIDS-defining opportunistic infection or malignancy. - AIDS related complex (ARC) patients with prior (within the last 12 months) or current history of diarrhea defined as = or > 3 liquid stools per day persisting for longer than 1 month. - Significant malabsorption: - Greater than 10 percent weight loss within past 3 months with serum carotene < 75 IU/ml or vitamin A < 75 IU/ml. - Significant cardiac, liver, renal, or neurologic disorder. - Active ARC-defining secondary infection (oral candidiasis, oral hairy leukoplakia, multidermatomal herpes zoster, recurrent nontyphoidal Salmonella bacteremia or Nocardiosis) undergoing therapy or prophylaxis within 7 days of study entry. - Active tuberculosis under treatment. - Concurrent neoplasm other than basal cell carcinoma of the skin or in situ carcinoma of the cervix. Concurrent Medication: Excluded: - Any medication that will interfere with the assessment of AL-721, including nutritional supplements, vitamins, laxatives, and over-the-counter products containing lecithin. - Chemoprophylaxis for Pneumocystis carinii (PCP), candida, herpes simplex, herpes zoster infections, or bacterial infections. - Intravenous topical or oral antifungal, antiviral, or antibiotic agents to treat oral candidiasis, herpes simplex, herpes zoster, or bacterial infections that develop during the course of the study. - Systemic chemotherapy. Prior Medication: Excluded within 30 days of study entry: - Any investigational drug. - Biologic response modifiers. - Corticosteroids. - Chemotherapeutic agents. - Excluded within 90 days of study entry: - Any antiretroviral agent or AL-721.
Total Enrollment: 50
Location and Contact Information:
Overall Study Official:
MildvanD, Study Chair,
Tulane Univ School of Medicine
New Orleans, Louisiana, 70112
United States
Beth Israel Med Ctr / Peter Krueger Clinic
New York City, New York, 10003
United States
Univ of Minnesota
Minneapolis, Minnesota, 55455
United States
Charity Hosp / Tulane Univ Med School
New Orleans, Louisiana, 70112
United States
Mem Sloan - Kettering Cancer Ctr
New York City, New York, 10021
United States
Bronx Veterans Administration / Mount Sinai Hosp
Bronx, New York, 10468
United States
Mount Sinai Med Ctr
New York City, New York, 10029
United States
Louisiana State Univ Med Ctr / Tulane Med School
New Orleans, Louisiana, 70112
United States
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
United States
Additional Information:
Study ID Numbers: ACTG 022;
Study Start Date:
Record last reviewed: September 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001012
Other Hiv Infections Studies:
1. A Comparison of DOX-SL Versus Adriamycin Plus Bleomycin Plus Vincristine in the Treatment of Severe AIDS-Related Kaposi's Sarcoma
2. A Phase I/II Study of Hyperimmune IVIG in Slowing Progression of Disease in HIV-Infected Children
3. The Safety and Effectiveness of Interleukin-2 Plus Zidovudine in Patients with AIDS or AIDS Related Complex
4. A Phase I/II Study of the Safety and Efficacy of Topical 1-(S)-(3-Hydroxy-2-phosphonylmethoxypropyl)cytosine Dihydrate (Cidofovir; HPMPC) in the Treatment of Refractory Mucocutaneous Herpes Simplex Disease in Patients With AIDS
5. The Safety and Effectiveness of Cidofovir in the Treatment of Venereal Warts in HIV-Infected Patients
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A Study of AL721 in HIV-Infected Patients with Swollen Lymph Nodes
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