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A phase II study of lopinavir/ritonavir in combination with saquinavir mesylate or lamivudine/zidovudine to explore metabolic toxicities in antiretroviral HIV-infected subjects Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about A phase II study of lopinavir/ritonavir in combination with saquinavir mesylate or lamivudine/zidovudine to explore metabolic toxicities in antiretroviral HIV-infected subjects conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. A phase II study of lopinavir/ritonavir in combination with saquinavir mesylate or lamivudine/zidovudine to explore metabolic toxicities in antiretroviral HIV-infected subjects Clinical research trials and A phase II study of lopinavir/ritonavir in combination with saquinavir mesylate or lamivudine/zidovudine to explore metabolic toxicities in antiretroviral HIV-infected subjects health trials occur in a lot of 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 potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including A phase II study of lopinavir/ritonavir in combination with saquinavir mesylate or lamivudine/zidovudine to explore metabolic toxicities in antiretroviral HIV-infected subjects. A phase II study of lopinavir/ritonavir in combination with saquinavir mesylate or lamivudine/zidovudine to explore metabolic toxicities in antiretroviral HIV-infected subjects Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a A phase II study of lopinavir/ritonavir in combination with saquinavir mesylate or lamivudine/zidovudine to explore metabolic toxicities in antiretroviral HIV-infected subjects clinical trial. Human subjects often get the best healthcare possible for their A phase II study of lopinavir/ritonavir in combination with saquinavir mesylate or lamivudine/zidovudine to explore metabolic toxicities in antiretroviral HIV-infected subjects condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > A phase II study of lopinavir/ritonavir in combination with saquinavir mesylate or lamivudine/zidovudine to explore metabolic toxicities in antiretroviral HIV-infected subjects  A phase II study of lopinavir/ritonavir in combination with saquinavir mesylate or lamivudine/zidovudine to explore metabolic toxicities in antiretroviral HIV-infected subjects
A phase II study of lopinavir/ritonavir in combination with saquinavir mesylate or lamivudine/zidovudine to explore metabolic toxicities in antiretroviral HIV-infected subjects
For Condition: HIV Infections
Status: No longer recruiting
Sponsor(s): Abbott Laboratories ,
Synopsis: The objectives of this study are to explore the metabolic toxicities associated with LPV/r plus INV versus LPV/r plus Combivir in antiretroviral naïve subjects and to assess the overall safety, tolerability and efficacy of LPV/r plus INV versus LPV/r plus Combivir in antiretroviral naïve subjects and to assess the pharmacokinetics of 400 mg INV BID, 600 mg INV BID and 800 mg INV BID in combination with 400 mg lopinavir/100 mg ritonavir plus 150 mg lamivudine/300 mg zidovudine BID.
Details:
Eligibility:
Study Type: Interventional,Treatment,Randomized,Open Label,Active Control,Parallel Assignment,Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: 1.Subject is naïve to antiretroviral treatment (subjects may not have more than 7 days of any antiretroviral treatment). 2.Subject is at least 18 years of age, inclusive. 3.If female, subject is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or is of childbearing potential and practicing one of the following methods of birth control:condoms, sponge, foams, jellies, diaphragm or intrauterine device(IUD), a vasectomized partner, total abstinence from sexual intercourse 4.If female, the results of a urine pregnancy test performed at screening (urine specimen obtained no earlier than 28 days prior to study drug administration) is negative. 5.Subject is not breast-feeding. 6.Vital signs, physical examination and laboratory results do not exhibit evidence of acute illness. 7.Subject has no significant history of cardiac, renal, neurologic, psychiatric, oncologic, endocrinologic, metabolic or hepatic disease that would in the opinion of the investigator adversely affect his/her participating in this study. 8.Subject does not require and agrees not to take any of the following medications for the duration of the study: midazolam, triazolam, terfenadine, astemizole, cisapride, pimozide, propafenone, flecainide, certain ergot derivatives (ergotamine, dihydroergotamine, ergonovine, and metheylergonovine), rifampin, lovastatin, simvastatin, and St. John’s wort. 9.Subject agrees not to take any medication during the study, including over-the-counter medicine, alcohol or recreational drugs without the knowledge and permission of the principal investigator. 10.Subject has not been treated for an active AIDS-defining opportunistic infection within 30 days of screening. 11.Subject has a plasma HIV RNA level of greater than 400 copies/mL at screening. 12.Subject agrees to take all doses of the study drug from the bottles provided by the sponsor (rather than other containers, i.e., “pill box”). 13.Subject has voluntarily signed and dated an informed consent form, approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC), after the nature of the study has been explained and the subject has had the opportunity to ask questions. The informed consent must be signed before any study-specific procedures are performed. Exclusion Criteria: 1.Subject has a history of an allergic reaction or significant sensitivity to LPV/r, INV or Combivir. 2.Subject has a history of substance abuse or psychiatric illness that could preclude adherence with the protocol. 3.Screening laboratory analyses show any of the following abnormal laboratory results: ·Hemoglobin 10.0 g/dL ·Absolute neutrophil count 1000 cells/µL ·Platelet count 50,000 per mL ·ALT or AST 3.0 x Upper Limit of Normal (ULN) ·Creatinine 1.5 x Upper Limit of Normal (ULN) 4.Subject has received any investigational drug within 30 days prior to study drug administration. 5.For any reason, subject is considered by the investigator to be an unsuitable candidate for the study.
Total Enrollment: 30
Location and Contact Information:
University of Ottawa at the Ottawa Health Research Institute
Ottawa, , K1H 8L6
Canada
Stephen Becker, MD
San Francisco, California, 94115
United States
Community Research Initiative of New England
Springfield, Massachusetts, 01107
United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
United States
Duke University Medical Center
Durham, North Carolina, 27710
United States
Community Research Initiative of New England
Boston, Massachusetts, 02215
United States
Harbor UCLA, Research & Education Institute
Torrance, California, 90502
United States
Additional Information:
Study ID Numbers: M01-384;
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00043953
Other Hiv Infections Studies:
1. Phase II Placebo Controlled Study of Thalidomide in Patients With Mycobacterial and HIV Infections
2. Safety and Efficacy of Zidovudine for Asymptomatic HIV-Infected Individuals
3. Interactions Between HIV Protease Inhibitors and Calcium Channel Blockers
4. A Multicenter, Randomized, Placebo-Controlled, Double-Blinded, Phase I Trial to Evaluate the Safety and Immunogenicity of Live Recombinant Canarypox ALVAC-HIV vCP205 Combined with GM-CSF in Healthy, HIV-1 Uninfected Volunteers
5. Studies of Influenza Vaccine and Tetanus-Pneumococcal Vaccine in HIV-infected Patients Receiving Interleukin-2
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A phase II study of lopinavir/ritonavir in combination with saquinavir mesylate or lamivudine/zidovudine to explore metabolic toxicities in antiretroviral HIV-infected subjects
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