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Treatment with Interleukin-2 (IL-2) Plus Combination Anti-HIV-Drug Therapy (HAART) for Patients Formerly in ACTG 328 Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on Treatment with Interleukin-2 (IL-2) Plus Combination Anti-HIV-Drug Therapy (HAART) for Patients Formerly in ACTG 328 conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Treatment with Interleukin-2 (IL-2) Plus Combination Anti-HIV-Drug Therapy (HAART) for Patients Formerly in ACTG 328 Clinical research trials and Treatment with Interleukin-2 (IL-2) Plus Combination Anti-HIV-Drug Therapy (HAART) for Patients Formerly in ACTG 328 healthcare trials occur in a lot of 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 does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including Treatment with Interleukin-2 (IL-2) Plus Combination Anti-HIV-Drug Therapy (HAART) for Patients Formerly in ACTG 328. Treatment with Interleukin-2 (IL-2) Plus Combination Anti-HIV-Drug Therapy (HAART) for Patients Formerly in ACTG 328 Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Treatment with Interleukin-2 (IL-2) Plus Combination Anti-HIV-Drug Therapy (HAART) for Patients Formerly in ACTG 328 clinical trial. Test subjects typically receive the most effective healthcare possible for their Treatment with Interleukin-2 (IL-2) Plus Combination Anti-HIV-Drug Therapy (HAART) for Patients Formerly in ACTG 328 condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "T" Clinical Trials Conditions > Treatment with Interleukin-2 (IL-2) Plus Combination Anti-HIV-Drug Therapy (HAART) for Patients Formerly in ACTG 328  Treatment with Interleukin-2 (IL-2) Plus Combination Anti-HIV-Drug Therapy (HAART) for Patients Formerly in ACTG 328
Treatment with Interleukin-2 (IL-2) Plus Combination Anti-HIV-Drug Therapy (HAART) for Patients Formerly in ACTG 328
For Condition: HIV Infections
Status: No longer recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: This study examines the long-term effects of interleukin-2 (IL-2) in combination with anti-HIV drugs, or highly active antiretroviral therapy (HAART). The purpose of this study is to see if IL-2 can increase the number of CD4 cells (cells of the immune system which fight infection) in HIV-infected patients who have completed ACTG 328. HAART is often successful in decreasing viral load (level of HIV in the blood), but these drugs have not been able to restore the immune systems of HIV-infected patients. IL-2 is a substance naturally produced by the body's immune cells. In ACTG 328, IL-2 is tested to see if it can increase the number of CD4 cells and "boost" a patient's immune system. This study is a follow-up to ACTG 328 so that patients who are benefiting from IL-2 can continue to take it and patients in the control group who do not receive IL-2 can start taking it.
Details: HIV disease is characterized by a progressive decline in CD4 cells and an increase in viral burden. Although antiretroviral therapy has been successful in controlling viral levels, its effects on CD4 cell counts have been modest. Intermittently administered IL-2 in the presence of HAART has been shown to increase CD4 cell counts, decrease lymphocyte activation markers, and increase certain lymphocyte functional activity in patients with early-stage HIV infection. ACTG 328 evaluated the effects of intravenous and/or subcutaneously administered IL-2 in conjunction with HAART in a group of more advanced HIV-infected patients over an 18- to 22-month period. As patients were enrolled in this study over an 18-month period, a follow-up protocol is required to provide continued IL-2 therapy for patients responding to IL-2 and patients in the control group who wish to receive this drug. This study enrolls patients who participated in ACTG 328. Patients in Arm I of ACTG 328 (the control group receiving HAART only) who have a viral load of 5,000 copies/ml or less register for Step II. Patients in Step II receive subcutaneous [SC] IL-2 in combination with HAART. IL-2 is administered for 5 days every 8 weeks for the first 3 cycles. For subsequent cycles, the interval between cycles may be extended in 8-week increments for a maximum of 24 weeks, provided the patient's bimonthly CD4 count exceeds 500 cells/mm3. Patients in Arm I who have a viral load greater than 5,000 copies/ml register for Step I which requires a change in antiretroviral therapy. Patients who then achieve viral levels of 5,000 copies/ml or less may begin to receive IL-2 no earlier than 4 weeks and no later than 12 weeks after the change in HAART regimen. Patients whose viral load remains above 5,000 copies/ml for 12 weeks after the change in drug regimen are discontinued from the study. Patients in Arms II or III of ACTG 328 (IL-2-containing arms) who have had a 25 percent or greater increase in CD4 cell count above their Week 11 value and have a viral load of 5,000 copies/ml or less continue on SC IL-2 and HAART. Patients who meet the CD4 criteria but whose viral load is above 5,000 copies/ml change their HAART regimen. After a minimum of 4 weeks and a maximum of 12 weeks, these patients may receive IL-2 provided they have a viral load of 5,000 copies/ml or less. For this study, HAART is defined as one protease inhibitor and two nucleoside analogues. [AS PER AMENDMENT 9/16/99: All patients must receive a protease inhibitor or, with permission of the chair, a nonnucleoside reverse transcriptase inhibitor (NNRTI) plus either two nucleoside reverse transcriptase inhibitors (NRTIs) or another protease inhibitor or NNRTI.] The protease inhibitor provided on this study is indinavir (IDV). The nucleoside analogue combinations provided on this study are as follows: zidovudine (ZDV) plus didanosine (ddI), ZDV plus lamivudine (3TC), stavudine (d4T) plus 3TC, or d4T plus ddI. Other antiretroviral drugs may be used but are not provided by this study. Patients are monitored for CD4 counts at bimonthly intervals after the first IL-2 dose. CD4 counts and plasma storage for HIV RNA are done within 96 hours prior to each cycle of IL-2. Safety laboratory evaluations are obtained prior to and at the conclusion of each IL-2 course. TSH (thyroid-stimulating hormone), DTH skin testing, and real-time plasma HIV RNA are obtained at 6-month intervals.
Eligibility:
Study Type: Interventional, Treatment, Safety Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients may be eligible for this study if they: - Are HIV-positive. - Have completed at least 84 weeks of treatment on ACTG 328. - Have had a 25 percent or greater increase in CD4 cell count above the ACTG 328 Week 11 value (only applies to patients who received IL-2 during ACTG 328). - Are 18 years of age or older. - Agree to practice abstinence or use a barrier method of birth control (such as condoms) during the study. (This study has been changed. Hormonal methods of birth control such as birth control pills are no longer allowed.) Exclusion Criteria Patients will not be eligible for this study if they: - Have significant heart disease or are taking certain heart medications. Patients with hypertension who are being treated are eligible. - Have taken certain medications that might affect the immune system within 4 weeks of study entry including corticosteroids, interferons, or thalidomide. - Have taken rifampin, rifabutin, or St. John's wort within 7 days of study entry. (This study has been changed. St. John's wort was not in the original version.) - Are taking certain investigational anti-HIV drugs. - Are taking indinavir and any of the following within 2 weeks of study entry: cisapride, terfenadine, astemizole, midazolam, triazolam, ketoconazole, itraconazole, or delavirdine. - Have cancer requiring chemotherapy. Local radiation therapy is allowed. - Have untreated thyroid disease. - Are allergic to albumin. - Have a serious mental illness. - Have a history of an autoimmune disease, including inflammatory bowel disease and psoriasis. - Have a central nervous system disease or seizures, if these have been active within 1 year prior to study entry. - Abuse drugs or alcohol. - Are pregnant or breast-feeding.
Total Enrollment: 110
Location and Contact Information:
Overall Study Official:
RonaldMitsuyasu, Study Chair,
Univ of North Carolina
Chapel Hill, North Carolina, 275997215
United States
Univ of Rochester Medical Center
Rochester, New York, 14642
United States
Beth Israel Deaconess - West Campus
Boston, Massachusetts, 02215
United States
St Louis Regional Hosp / St Louis Regional Med Ctr
St. Louis, Missouri, 63112
United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262
United States
Cornell Univ Med Ctr
New York City, New York, 10021
United States
Stanford Univ Med Ctr
Stanford, California, 943055107
United States
Tulane Univ School of Medicine
New Orleans, Louisiana, 70112
United States
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, 900331079
United States
Harbor UCLA Med Ctr
Torrance, California, 90502
United States
Case Western Reserve Univ
Cleveland, Ohio, 44106
United States
Beth Israel Med Ctr
New York City, New York, 10003
United States
UCLA CARE Ctr
Los Angeles, California, 90095
United States
Univ of Texas Galveston
Galveston, Texas, 775550435
United States
Duke Univ Med Ctr
Durham, North Carolina, 27710
United States
Ohio State Univ Hosp Clinic
Columbus, Ohio, 432101228
United States
Univ of Hawaii
Honolulu, Hawaii, 96816
United States
Queens Med Ctr
Honolulu, Hawaii, 96816
United States
Univ of Iowa Hosp and Clinic
Iowa City, Iowa, 52242
United States
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294
United States
Mount Sinai Med Ctr
New York City, New York, 10029
United States
Univ of Washington
Seattle, Washington, 98104
United States
Julio Arroyo
West Columbia, South Carolina, 29169
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
Additional Information:
Study ID Numbers: ACTG A5051; Substudy ACTG A5052s,Substudy ACTG A5053s,Substudy ACTG A5054s,Substudy ACTG A5094s,AACTG A5051
Study Start Date: October 1998
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000923
Other Hiv Infections Studies:
1. A Phase I/II Double-Blind Controlled Trial to Determine the Safety and Immunogenicity of HIV-1 MN rgp160 Immuno AG Vaccine Therapy in HIV-Infected Individuals with Greater than or Equal to 500/mm3 CD4+ T Cells and 200-400/mm3 CD4+ T Cells
2. A Phase I Concentration-Controlled Trial to Assess the Safety, Tolerance, Pharmacokinetics and Development of Decreased HIV-1 Susceptibility to the Combination of Atevirdine Mesylate (U-87201E), Zidovudine (AZT), and Didanosine (ddI)
3. An Open Trial of Zidovudine (AZT) Treatment of the AIDS Dementia Complex in Patients With AIDS or Low CD4+ Lymphocyte Counts
4. The Effects of Treatment for Mycobacterium Avium Complex (MAC) on the Cells of HIV-Infected Patients
5. The Effectiveness of Two Anti-HIV Treatments in HIV-Infected Patients
Related Studies:
Other HIV Infections Clinical Trials
Other Ohio Clinical Trials
Other Cleveland Clinical Trials
Treatment with Interleukin-2 (IL-2) Plus Combination Anti-HIV-Drug Therapy (HAART) for Patients Formerly in ACTG 328
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