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A Study of ABT-378/Ritonavir in HIV-Infected Patients Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on A Study of ABT-378/Ritonavir in HIV-Infected Patients conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. A Study of ABT-378/Ritonavir in HIV-Infected Patients Clinical research trials and A Study of ABT-378/Ritonavir in HIV-Infected Patients medical trials occur in many of places across 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 generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including A Study of ABT-378/Ritonavir in HIV-Infected Patients. A Study of ABT-378/Ritonavir in HIV-Infected Patients Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a A Study of ABT-378/Ritonavir in HIV-Infected Patients clinical trial. Participants oftentimes recieve the finest healthcare available for their A Study of ABT-378/Ritonavir in HIV-Infected Patients condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A Study of ABT-378/Ritonavir in HIV-Infected Patients A Study of ABT-378/Ritonavir in HIV-Infected Patients
A Study of ABT-378/Ritonavir in HIV-Infected Patients
For Condition: HIV Infections
Status: No longer recruiting
Sponsor(s): Abbott Laboratories ,
Synopsis: The purpose of this study is to see if it is safe and effective to give ABT-378/ritonavir to HIV-infected patients who have never been treated with anti-HIV drugs. This study also examines how the body handles ABT-378/ritonavir.
Details: This is a Phase I/II randomized, ABT-378 dose-blinded, multicenter study of ABT-378/ritonavir in combination with stavudine (d4T) and lamivudine (3TC) in 32 HIV-infected otherwise healthy men and women.
Eligibility:
Study Type: Interventional, Treatment, Pharmacokinetics Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Patients must have: - Documented HIV infection. - HIV RNA equal to or greater than 5,000 copies/ml. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: - Evidence of acute infection, as measured by vital signs, physical examination, and laboratory assessments. - Clinically significant abnormal ECG results. - Positive Hepatitis B surface antigen or anti-HCV antibodies test at screening. Concurrent Medication: Excluded: - Midazolam, triazolam, terfenadine, astemizole, cisapride, pimozide, ergotamine, and dihydroergotamine. - Over-the-counter medications, without permission from the lead investigator. Patients with the following prior conditions are excluded: - Prior antiretroviral therapy. - History of significant drug hypersensitivity. - History of psychiatric illness that would preclude compliance with the protocol. Prior Medication: Excluded: - Midazolam, triazolam, terfenadine, astemizole, cisapride, pimozide, ergotamine, and dihydroergotamine within 28 days prior to drug administration. - Investigational drugs and over-the-counter medicine within 28 days prior to drug administration. - Antiretroviral therapy. Risk Behavior: Excluded: Active substance abuse. (NOTE: - With the exception of cannabis, unless the lead investigator anticipates cannabis use will interfere with compliance with the study.)
Total Enrollment: 32
Location and Contact Information:
New England Deaconess Hosp
Boston, Massachusetts, 02215
United States
Pacific Oaks Research
Beverly Hills, California, 90211
United States
Northwestern Univ Med Ctr
Chicago, Illinois, 60611
United States
Duke Univ Med Ctr
Durham, North Carolina, 27710
United States
Univ of North Carolina / Infectious Disease Division
Chapel Hill, North Carolina, 27599
United States
Additional Information:
Study ID Numbers: 285A; M97-720
Study Start Date:
Record last reviewed: June 1998
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004578
Other Hiv Infections Studies:
1. A Study of Nonoxynol-9 (N-9) and HIV Infection
2. A Treatment Protocol for the Use of Intravenous Ganciclovir in AIDS Patients With Immediately Sight-Threatening CMV Retinitis
3. Nitazoxanide for the Treatment of Chronic Diarrhea in HIV Infected Children
4. A Phase II Double-Blind Study of Delavirdine Mesylate ( U-90152 ) in Combination With Zidovudine ( AZT ) and/or Didanosine ( ddI ) Versus AZT and ddI Combination Therapy
5. A Randomized, Open-Label Study of Alternative Treatment Combinations of Dideoxycytidine (HIVID; ddC) and Zidovudine (AZT) in Patients With HIV Infection
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A Study of ABT-378/Ritonavir in HIV-Infected Patients
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