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Safety and Effectiveness of L2-7001 (Interleukin-2) in HIV-Positive Patients Receiving Anti-HIV Therapy Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on Safety and Effectiveness of L2-7001 (Interleukin-2) in HIV-Positive Patients Receiving Anti-HIV Therapy conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Safety and Effectiveness of L2-7001 (Interleukin-2) in HIV-Positive Patients Receiving Anti-HIV Therapy Clinical research trials and Safety and Effectiveness of L2-7001 (Interleukin-2) in HIV-Positive Patients Receiving Anti-HIV Therapy healthcare trials occur in a lot of of places throughout 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 potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including Safety and Effectiveness of L2-7001 (Interleukin-2) in HIV-Positive Patients Receiving Anti-HIV Therapy. Safety and Effectiveness of L2-7001 (Interleukin-2) in HIV-Positive Patients Receiving Anti-HIV Therapy Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a Safety and Effectiveness of L2-7001 (Interleukin-2) in HIV-Positive Patients Receiving Anti-HIV Therapy clinical trial. Participants typically obtain the most effective healthcare available for their Safety and Effectiveness of L2-7001 (Interleukin-2) in HIV-Positive Patients Receiving Anti-HIV Therapy condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "S" Clinical Trials Conditions > Safety and Effectiveness of L2-7001 (Interleukin-2) in HIV-Positive Patients Receiving Anti-HIV Therapy  Safety and Effectiveness of L2-7001 (Interleukin-2) in HIV-Positive Patients Receiving Anti-HIV Therapy
Safety and Effectiveness of L2-7001 (Interleukin-2) in HIV-Positive Patients Receiving Anti-HIV Therapy
For Condition: HIV Infections
Status: No longer recruiting
Sponsor(s): Chiron Corporation ,
Synopsis: The purpose of this study is to see if it is safe and effective to give HIV-positive patients L2-7001 (a type of interleukin-2) plus anti-HIV therapy. Interleukin-2 (IL-2) is a substance naturally produced by the body's white blood cells that plays an important role in helping the body fight infection. IL-2 may be able to boost the immune systems of people with HIV infection.
Details: This study takes place in two phases. Phase A consists of an open-label dose-escalation of L2-7001 through four dose levels. Ascending dose cohorts of five patients are studied. The safety and tolerability of L2-7001 is assessed in preparation for the second phase of the study and to estimate an MTD. Phase B involves randomization of 190 patients to (a) one of three dose levels of L2-7001 plus ART, (b) one of two dosing levels of Proleukin plus ART, or (c) ART alone. L2-7001 and Proleukin are given SC every 12 hours for the first 5 days of an 8-week cycle for three cycles. Serum IL-2 levels, soluble IL-2 receptor levels, and levels of pro-inflammatory cytokines are evaluated in 8 patients randomized to each treatment cohort of Phase B. All patients completing this phase of the protocol are eligible to be screened for enrollment in a maintenance use protocol which will allow for access to L2-7001.
Eligibility:
Study Type: Interventional, Treatment, Dose Comparison, 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 a viral load below 10,000 copies/ml. - Have a CD4 count between 300 and 500 cells/mm3. - Have been on stable anti-HIV therapy for 4 months. Patients must be taking at least 2 drugs, 1 of which must be a protease inhibitor or a nonnucleoside drug (NNRTI). - Are at least 18 years old. - Agree to use an effective barrier method of birth control, such as condoms, during the study. Exclusion Criteria Patients will not be eligible for this study if they: - Have an AIDS-defining illness. (Patients who have had an AIDS-defining illness that was cured may still be eligible.) - Have an alcohol or drug abuse problem that the doctors feel would affect their ability to participate. - Have cancer requiring chemotherapy. - Have a history of autoimmune disease. - Have uncontrolled diabetes or certain thyroid problems. - Have mental illness or other serious medical condition that the doctors feel would affect their ability to participate. - Have received IL-2 in the past. - Have taken corticosteroids or certain medications that affect the immune system in the past 4 weeks. - Have taken hydroxyurea in the past 4 months. - Are pregnant or breast-feeding.
Total Enrollment: 212
Location and Contact Information:
Specialty Med Care Ctrs of South Florida Inc
Miami, Florida, 33142
United States
Denver Inf Disease Consultants
Denver, Colorado, 80220
United States
Northstar Med Clinic
Chicago, Illinois, 60657
United States
Albany Med College
Albany, New York, 12208
United States
Virginia Mason Med Ctr
Seattle, Washington, 98101
United States
Central Texas Clinical Research
Austin, Texas, 78705
United States
AIDS Research Alliance - Chicago
Chicago, Illinois, 60657
United States
St Lukes Medical Group
San Diego, California, 92101
United States
Dupont Circle Physicians Group
Washington D.C., District of Columbia, 200091104
United States
Fenway Community Health Ctr
Boston, Massachusetts, 02115
United States
Orange County Ctr for Special Immunology
Fountain Valley, California, 92708
United States
Research and Education Group
Portland, Oregon, 97210
United States
N Texas Ctr for AIDS & Clin Rsch
Dallas, Texas, 75219
United States
Community AIDS Resource Inc
Coral Gables, Florida, 33146
United States
Anderson Clinical Research Inc
Rego Park, New York, 11374
United States
Steinhart Medical Associates
Miami, Florida, 33133
United States
Gathe, Joseph, M.D.
Houston, Texas, 77004
United States
Sorra Research Ctr / Med Forum
Birmingham, Alabama, 35203
United States
Anderson Clinical Research
Pittsburgh, Pennsylvania, 15221
United States
Pacific Oaks Research
Beverly Hills, California, 90211
United States
North Jersey Community Research Initiative
Newark, New Jersey, 071032842
United States
Associates in Med and Mental Health
Tulsa, Oklahoma, 74114
United States
Kaiser Foundation Hospital
San Francisco, California, 94118
United States
Additional Information:
Study ID Numbers: B007; CS-MM-9901
Study Start Date: August 1999
Record last reviewed: July 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002449
Other Hiv Infections Studies:
1. A Study to Evaluate the Safety and Tolerance of Stavudine (d4T) in Combination with Lamivudine (3TC) in HIV-Positive Pregnant Women and Their Infants
2. A Phase I Safety and Immunogenicity Trial of HIV-1 gp120 C4-V3 Hybrid Polyvalent Peptide Immunogen Mixed in Mineral Oil Containing Mannose Mono-Oleate (IFA)
3. Effectiveness of Interleukin-2 (IL-2) Plus Anti-HIV Therapy in HIV-Positive Patients
4. Safety and Tolerance of Indinavir plus Ritonavir in HIV-Positive Patients Failing Therapy with Amprenavir, Nelfinavir, or Saquinavir
5. A Study of MDL 28,574A in HIV-Infected Patients
Related Studies:
Other HIV Infections Clinical Trials
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Safety and Effectiveness of L2-7001 (Interleukin-2) in HIV-Positive Patients Receiving Anti-HIV Therapy
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