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Safety and Effectiveness of the Oral HIV Entry Inhibitor SCH 417690 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 Safety and Effectiveness of the Oral HIV Entry Inhibitor SCH 417690 in HIV Infected Patients conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Safety and Effectiveness of the Oral HIV Entry Inhibitor SCH 417690 in HIV Infected Patients Clinical research trials and Safety and Effectiveness of the Oral HIV Entry Inhibitor SCH 417690 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 Safety and Effectiveness of the Oral HIV Entry Inhibitor SCH 417690 in HIV Infected Patients. Safety and Effectiveness of the Oral HIV Entry Inhibitor SCH 417690 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 Safety and Effectiveness of the Oral HIV Entry Inhibitor SCH 417690 in HIV Infected Patients clinical trial. Participants oftentimes recieve the most expert healthcare available for their Safety and Effectiveness of the Oral HIV Entry Inhibitor SCH 417690 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 > "S" Clinical Trials Conditions > Safety and Effectiveness of the Oral HIV Entry Inhibitor SCH 417690 in HIV Infected Patients  Safety and Effectiveness of the Oral HIV Entry Inhibitor SCH 417690 in HIV Infected Patients
Safety and Effectiveness of the Oral HIV Entry Inhibitor SCH 417690 in HIV Infected Patients
For Condition: HIV Infections
Status: Not yet recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: New treatment options are critical for treatment-experienced HIV infected patients with drug resistance. HIV entry inhibitors have been shown effective in patients with resistance to other anti-HIV drugs. This study will test the safety and effectiveness of three different doses of SCH 417690 (formerly known as Schering D or SCH-D) in HIV infected patients.
Details: SCH 417690 is an oral HIV-1 entry inhibitor that targets the CCR5 receptor of T cells. SCH 417690 has been shown safe, well-tolerated, and active in Phase I clinical trials in treatment-naive HIV infected patients. The goal of this study is to evaluate the antiretroviral activity of three dose levels of SCH 417690 in HIV infected, treatment experienced patients who are failing their current ritonavir-containing antiretroviral therapy (ART). The study will last a maximum of 48 weeks. Patients will be randomly assigned to one of 4 groups. Group 1 will receive placebo; Group 2 will receive 5 mg SCH 417690 daily; Group 3 will receive 10 mg SCH 417690 daily; and Group 4 will receive 15 mg SCH 417690 daily. All patients will continue their current ART (not provided by the study). After two weeks, patients will receive ART optimized by the results of genotypic/phenotypic testing performed at study screening. Physical exams and blood work will occur at study entry, Day 4, and Weeks 1, 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48. Additionally, blood will be drawn twice, at least 2 hours apart, at both Weeks 2 and 8 for SCH 417690 pharmacokinetic analysis. Patients will undergo an electrocardiogram (EKG) at Weeks 2, 8, 24, and 48. Patients will be assessed for peripheral neuropathy at study entry and Weeks 24 and 48, and will be asked to complete an adherence questionnaire at entry and Weeks 2, 8, 16, 24, 32, 40, and 48.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria for Step 1: - HIV infected - Experiencing virologic failure on current ART regimen - Current ART regimen contains ritonavir (100 to 800 mg/day) and has been stable for at least 8 weeks prior to study entry. If amprenavir or fosamprenavir is part of the regimen, 200 to 800 mg/day ritonavir must be used for at least 2 weeks prior to study entry. - Experienced virologic failure on at least one ART regimen containing 3 or more drugs prior to current failing regimen - CD4 count of 50 cells/mm3 or more within 6 weeks prior to study entry - HIV viral load of 5000 copies/ml or more within 6 weeks prior to study entry - HIV strain of R5-only phenotype within 6 weeks prior to study entry - Willing to use acceptable forms of contraception - Able and willing to adhere to study dose and visit schedule Exclusion Criteria for Step 1: - Hepatitis C antibody and RNA positive - Hepatitis B surface antigen positive - Efavirenz or nevirapine use within 8 weeks of study entry - Vaccination within 2 weeks prior to study screening - Investigational agents within 30 days prior to study entry - Systemic cancer chemotherapy or other systemic cytotoxic agents within 30 days prior to study entry - Immunosuppressants within 30 days prior to study entry. Systemic corticosteroids at replacement doses (10 mg/day prednisone or less) are not excluded. - Immunomodulators within 30 days prior to study entry - Considered at risk for seizure: history of seizure, recent history of head trauma with loss of consciousness, central nervous system (CNS) tumors, or other CNS problems that, in the opinion of the investigator, pose increased risk for seizure - Medications to prevent seizures or with the potential to cause seizures within 30 days prior to study entry - Allergy to SCH 417690 or its components - Alcohol or drug abuse that, in the opinion of the investigator, would interfere with the study - Serious illness requiring systemic treatment or hospitalization. A patient who is clinically stable on therapy is not excluded. - Any clinically significant disease or condition that, in the opinion of the investigator, may interfere with the study - Certain medications - Pregnancy or breastfeeding
Total Enrollment: 120
Location and Contact Information:
Overall Study Official:
RoyGulick, Study Chair, Cornell HIV Clinical Trials Unit
Boston Medical Center (Harvard)
Boston, Massachusetts, 02118
United States
Betsy Adams 617-414-7082
Additional Information:
Study ID Numbers: ACTG A5211;
Study Start Date:
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00082498
Other Hiv Infections Studies:
1. A Pilot Study of Oral Clindamycin and Pyrimethamine for the Treatment of Toxoplasmic Encephalitis in Patients With AIDS
2. The Safety and Effectiveness of Clarithromycin Plus Zidovudine or Dideoxyinosine in the Treatment of Mycobacterium Avium Complex (MAC) Infections in Children with AIDS
3. A Study to Compare Anti-HIV Drugs Given Twice a Day or Once a Day, With or Without Direct Observation
4. A Phase I/II Dose Escalation Study of Intradermal gp160 to Evaluate Safety, Delayed Type Hypersensitivity (Skin Test) Responses and Immunogenicity in Asymptomatic HIV Seropositive Patients With More Than 400 CD4+ Cells
5. A Treatment IND for Retrovir Brand Zidovudine (AZT) Therapy of Pediatric Patients With HIV Disease
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Safety and Effectiveness of the Oral HIV Entry Inhibitor SCH 417690 in HIV Infected Patients
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