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A Study of ABT-378/Ritonavir in HIV-Infected Patients Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about A Study of ABT-378/Ritonavir in HIV-Infected Patients conditions. Clinical Trials Search.org is a site devoted 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 happen in hundreds 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 usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as 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 allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get 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 frequently get the best healthcare available for their A Study of ABT-378/Ritonavir in HIV-Infected Patients condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting 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. The Safety and Effectiveness of HBY 097 Used with or without AZT in HIV-Infected Patients Who Have Mild or No Symptoms
2. Phase I Study of Safety, Tolerability, and Pharmacokinetics of Viracept in HIV-1 Infected Children and Exposed Infants
3. A Phase I Multicenter Clinical Trial to Evaluate the Safety and Immunogenicity of Vaccinia Derived HIV-1 Recombinant Envelope Glycoprotein (gp160) of Human Immunodeficiency Virus: Evaluation of Accelerated Schedules
4. A Study of Male Rectal Samples in Preparation for Future Rectal Microbicide Trials
5. A Phase I, Observer-Blind, Placebo-Controlled Study of the Chiron Vaccine HIV p24/MF59 Administered to Healthy HIV-Seronegative Adults
Related Studies:
Other HIV Infections Clinical Trials
Other North Carolina Clinical Trials
Other Chapel Hill Clinical Trials
A Study of ABT-378/Ritonavir in HIV-Infected Patients
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