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Sponsors and Collaborators: |
Oklahoma State University Center for Health Sciences Abbott |
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Information provided by: | Oklahoma State University Center for Health Sciences |
ClinicalTrials.gov Identifier: | NCT00679926 |
Once daily antiretroviral therapy with Viread (tenofovir DF, 300mg) plus Kaletra (LPV/r, 800mg/200mg) will be effective in suppressing and maintaining suppression of HIV RNA to <50 copies/ml in antiretroviral naïve patients through 48 weeks of therapy.
Condition | Intervention | Phase |
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HIV Infections |
Drug: Lopinavir/ritonavir and tenofovir |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study |
Official Title: | A Phase IV Open Label Investigation of the Efficacy and Durability of Once Daily Antiretroviral Therapy With Kaletra and Viread in Antiretroviral Naïve Patients. |
Estimated Enrollment: | 30 |
Study Start Date: | May 2008 |
Estimated Study Completion Date: | May 2010 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Patients taking lopinavir/ritonavir and tenofovir once daily.
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Drug: Lopinavir/ritonavir and tenofovir
Four tablets of lopinavir/ritonavir and one tablet of tenofovir given once daily
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This study is a phase IV prospective, open-label, controlled treatment protocol consisting of once daily Kaletra dosed at 800mg lopinavir with 200mg ritonavir in four combination tablets plus Viread dosed as 300 mg tenofovir DF. This will be a single site, multi-investigator, study for 48 weeks. Consecutive eligible patients will be enrolled into the study to reach the enrollment goal of 30 patients. Eligible patients will be identified and screened during routine initial or follow-up visits at the Internal Medicine Specialty Services Clinic. This clinic serves as the HIV/AIDS specialty care clinic and is a subdivision of the Department of Internal Medicine, Oklahoma State University Center for Health Sciences College of Osteopathic Medicine. The study site currently serves >700 persons living with HIV in northeast Oklahoma with four to five antiretroviral naïve patients seen each week.
Patients meeting all inclusion criteria will receive routine standard of care for our program as prescribed by the DHHS guidelines. Patients will have a Complete Blood Count (CBC), Complete Metabolic Profile (CMP), fasting lipid profile, CD4 count, HIV-1 RNA level, and other prescribed or indicated laboratory preformed at baseline and throughout the study as described in the Visits and Evaluations section of this protocol. All of the aforementioned laboratory tests will be performed at the Diagnostic Laboratories of Oklahoma, a division of Quest Diagnostics. Any antiretroviral resistance testing will be performed at Virologic Labs, Inc. Adherence will be assessed at discontinuation of the study and when indicated for evaluation of virologic failure by Memory Electronic Monitoring Systems caps and pharmacy refill data. Patients will be monitored at each study visit for tolerability and adverse events. Patients who develop a study related Grade 1 or 2 Adverse Events (Aes) may continue the study. Those who develop Grade 3 or 4 AEs will have study medications discontinued. Patients with asymptomatic elevations of triglyceride or Low Density Lipoprotein (LDL) cholesterol levels may be treated with appropriate lipid lowering therapy at the investigators discretion.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Female patients must meet these additional criteria
Exclusion Criteria:
Presence of any of the following:
Contact: Johnny R Stephens, Pharm.D. | 918-382-5058 |
United States, Oklahoma | |
OSU Internal Medicine Specialty Clinic | Recruiting |
Tulsa, Oklahoma, United States, 74127 | |
Contact: Johnny Stephens, Pharm.D. 918-382-5058 | |
Principal Investigator: Damon Baker, DO | |
Sub-Investigator: Scott Hendrickson, DO | |
Sub-Investigator: Johnny Stephens, Pharm.D. |
Principal Investigator: | Damon Baker, D.O. | Oklahoma State University Center for Health Sciences |
Responsible Party: | Oklahoma State University Center for Health Sciences ( Damon Baker, D.O. ) |
Study ID Numbers: | Baker - 001 |
Study First Received: | May 15, 2008 |
Last Updated: | June 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00679926 |
Health Authority: | United States: Institutional Review Board |
HIV AIDS HIV/AIDS Treatment Naive |
Virus Diseases Sexually Transmitted Diseases, Viral Lopinavir Ritonavir HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Tenofovir Retroviridae Infections Immunologic Deficiency Syndromes Tenofovir disoproxil |
Anti-Infective Agents RNA Virus Infections HIV Protease Inhibitors Slow Virus Diseases Anti-HIV Agents Immune System Diseases Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Infection |
Antiviral Agents Pharmacologic Actions Reverse Transcriptase Inhibitors Protease Inhibitors Anti-Retroviral Agents Therapeutic Uses Lentivirus Infections Nucleic Acid Synthesis Inhibitors |