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An Escalating Dose Tolerance Trial of BG8962 (rCD4) in Patients Who Are HIV Antibody Positive Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about An Escalating Dose Tolerance Trial of BG8962 (rCD4) in Patients Who Are HIV Antibody Positive conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. An Escalating Dose Tolerance Trial of BG8962 (rCD4) in Patients Who Are HIV Antibody Positive Clinical research trials and An Escalating Dose Tolerance Trial of BG8962 (rCD4) in Patients Who Are HIV Antibody Positive health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including An Escalating Dose Tolerance Trial of BG8962 (rCD4) in Patients Who Are HIV Antibody Positive. An Escalating Dose Tolerance Trial of BG8962 (rCD4) in Patients Who Are HIV Antibody Positive Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a An Escalating Dose Tolerance Trial of BG8962 (rCD4) in Patients Who Are HIV Antibody Positive clinical trial. Test subjects typically receive the most expert healthcare available for their An Escalating Dose Tolerance Trial of BG8962 (rCD4) in Patients Who Are HIV Antibody Positive condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > An Escalating Dose Tolerance Trial of BG8962 (rCD4) in Patients Who Are HIV Antibody Positive  An Escalating Dose Tolerance Trial of BG8962 (rCD4) in Patients Who Are HIV Antibody Positive
An Escalating Dose Tolerance Trial of BG8962 (rCD4) in Patients Who Are HIV Antibody Positive
For Condition: HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , Biogen Idec
Synopsis: To determine the maximal safe daily dose of BG8962 (rCD4) which can be administered by continuous subcutaneous infusion (CSCI) over 24 hours; to determine the pharmacokinetics of BG8962 when it is administered by intramuscular and subcutaneous routes; and to look for dose related antiviral activity determined by quantitation of infectious HIV peripheral blood leukocytes (PBLs) and plasma, and by monitoring the blood levels of viral p24 antigen (when present), CD4+ T-cells, and Beta-2- microglobulin. Recombinant soluble CD4 protein (rCD4) is a drug that has been produced by genetic engineering techniques. In laboratory studies, rCD4 binds to HIV and reduces its ability to enter the cell, thus inhibiting its reproduction. Before rCD4 can be tested for therapeutic effectiveness in HIV-infected patients, it is necessary to determine the maximum dose that can be tolerated by humans. AMENDED: To date, Biogen's original sequence recombinant soluble CD4 and Biogen's natural sequence recombinant soluble CD4 have both been referred to as recombinant soluble CD4 (rsCD4). In order to distinguish between these two products, a change in nomenclature has been made. In this protocol, whenever the original sequence CD4 molecule is referred to, it is called recombinant soluble T4 (rsT4). Whenever the natural sequence molecule (currently under study in this protocol) is referred to, it is called BG8962 or rCD4. Whenever the drug is discussed generically, it is referred to as rsCD4.
Details: Recombinant soluble CD4 protein (rCD4) is a drug that has been produced by genetic engineering techniques. In laboratory studies, rCD4 binds to HIV and reduces its ability to enter the cell, thus inhibiting its reproduction. Before rCD4 can be tested for therapeutic effectiveness in HIV-infected patients, it is necessary to determine the maximum dose that can be tolerated by humans. AMENDED: To date, Biogen's original sequence recombinant soluble CD4 and Biogen's natural sequence recombinant soluble CD4 have both been referred to as recombinant soluble CD4 (rsCD4). In order to distinguish between these two products, a change in nomenclature has been made. In this protocol, whenever the original sequence CD4 molecule is referred to, it is called recombinant soluble T4 (rsT4). Whenever the natural sequence molecule (currently under study in this protocol) is referred to, it is called BG8962 or rCD4. Whenever the drug is discussed generically, it is referred to as rsCD4. The initial dose level is the highest dose previously established with other patients in this trial to be safe when administered intramuscularly (IM). Dose escalation is by semilogarithmic steps. A shift from IM injection to continuous subcutaneous infusion (CSCI) is necessitated by the volume of drug which is administered as part of the escalation dose. Three groups of eight patients each are treated as follows. The first group of 8 patients receives BG8962 daily and consists of two cohorts of four patients each. One cohort receives BG8962 as an IM injection. The second cohort receives BG8962 as a continuous 24 hour infusion. All patients in this group are treated for 12 weeks. The second dosing group of 8 patients receive daily BG8962 by CSCI for 12 weeks. The third group of 8 patients receive BG8962 by CSCI for 6 weeks. Every two weeks during the study the following tests and evaluations are done: Blood chemistry, hematology, urinalysis with microscopic exam, and T-cells and T-cell subsets.
Eligibility:
Study Type: Interventional, Treatment, Open Label
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - Nystatin or clotrimazole for suppression of oral thrush. - Aerosolized pentamidine for Pneumocystis prophylaxis in Group A patients. - Trimethoprim / sulfamethoxazole for Pneumocystis prophylaxis in patients who are hematologically stable on trimethoprim / sulfamethoxazole. Patients must have: - Group A: AIDS and symptoms defined in disease status. - Group B: AIDS related complex (ARC) and symptoms defined in disease status. Exclusion Criteria Co-existing Condition: Patients with the following disease or conditions are excluded: - Malignancies other than Kaposi's sarcoma. - AIDS dementia. - Opportunistic infections requiring ongoing therapy except oral thrush suppression with nystatin or clotrimazole or Pneumocystis prophylaxis in Group A patients. - Significant organ system dysfunction including: - Granulocytopenia with a granulocyte count < 1000 cells/mm3. - Thrombocytopenia - < 75000 platelets/mm3. - Anemia with a hemoglobin < 9.5 g/dl. - Renal dysfunction - creatinine > 2 mg/dl. - Hepatic dysfunction with enzymes or bilirubin > 3 x upper limit of normal. Patients with the following are excluded: - Preexisting antibodies to rCD4. - Malignancies other than Kaposi's sarcoma. - AIDS-dementia complex. - Opportunistic infections requiring ongoing therapy. - Significant organ system dysfunction. - Inability to sign voluntarily the consent form. Prior Medication: Excluded: - Recombinant soluble CD4 protein (rCD4). - Excluded within 30 days of study entry: - Immunomodulatory therapy or agent with anti-HIV activity. - Chemotherapy. Prior Treatment: Excluded within 30 days of study entry: - Radiotherapy. Active illicit drug use or alcohol abuse at time of entry.
Total Enrollment: 85
Location and Contact Information:
Overall Study Official:
SchooleyRT, Study Chair,
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, 02114
United States
Tulane Univ School of Medicine
New Orleans, Louisiana, 70112
United States
Stanford Univ Med Ctr
Stanford, California, 943055107
United States
Stanford Univ School of Medicine
Stanford, California, 94305
United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
United States
City Hosp
Edinburgh, ,
United Kingdom
Cedars Sinai Med Ctr
Los Angeles, California, 90048
United States
Additional Information:
Study ID Numbers: ACTG 066; 066 Extension
Study Start Date:
Record last reviewed: March 1992
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000721
Other Hiv Infections Studies:
1. A Phase I Study to Evaluate the Pharmacokinetics, Safety and Antiviral Effects of Concurrent Administration of Zidovudine (AZT) and 2'3'-Dideoxyinosine (ddI) in Patients With Human Immunodeficiency Virus (HIV)
2. A Study of Psychosocial and Behavioral Determinants of Differential Rates of Participant Compliance in CPCRA Protocols
3. Interactions Between HIV Protease Inhibitors and Calcium Channel Blockers
4. Phase II Study of Novantrone(R) (Mitoxantrone) and Etoposide in Patients with HIV Associated Large Cell and Immunoblastic Lymphomas
5. Pulmonary Complications of HIV Infection Study (PACS)
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An Escalating Dose Tolerance Trial of BG8962 (rCD4) in Patients Who Are HIV Antibody Positive
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