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Raltegravir vs. Atazanavir in Combination With Truvada® for the Treatment of Antiretroviral naïve HIV Infected Patients (RAN)

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ClinicalTrials.gov Identifier: NCT00762892
Recruitment Status : Completed
First Posted : September 30, 2008
Results First Posted : January 5, 2015
Last Update Posted : January 5, 2015
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Tanvir K. Bell, MD, The University of Texas Health Science Center, Houston

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This is a pilot that will evaluate two regimens for treating HIV infected patients that haven't been on treatment before. HIV/AIDS patients may have an increased risk of myocardial infarction and antiretroviral therapy used may contribute to this. We will evaluate virological, immunological and cardiovascular effects of two HIV treatment regimens.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Raltegravir and truvada Drug: Atazanavir, Norvir and Truvada Phase 4

Detailed Description:
We will check blood studies used to evaluate HIV patients response to therapy including CD4 count and HIV viral load test. We will check routine safety labs done on HIV patients and also check homocysteine levels and creatine kinase level. We will evaluate homocysteine and IL6 levels at baseline, week 48, and week 96.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study--randomized, Prospective, Single Site Trial Evaluating Raltegravir vs. Atazanavir in Combination With Truvada® for the Treatment of Antiretroviral naïve HIV Infected Patients
Study Start Date : January 2009
Actual Primary Completion Date : December 2012
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Raltegravir
Raltegravir in combination with truvada (tenofovir and emtricitabine)
 Drug: Raltegravir and truvada
Raltegravir 400 mg po bid, truvada 1 tab q daily
Other Name: Truvada is tenofovir 300 mg and emtricitabine 200 mg
Active Comparator: Atazanavir
Atazanavir, low dose ritonavir, and truvada (tenofovir and emtricitabine)
 Drug: Atazanavir, Norvir and Truvada
Atazanavir 300 mg po q daily, Norvir 100 mg po q daily and Truvada 1 tablet po q daily
Other Name: Truvada is tenofovir 300 mg and emtricitabine 200 mg


Outcome Measures
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Primary Outcome Measures :
  1. Change From Baseline in CD4 Count at 48 Weeks [ Time Frame: Baseline and 48 weeks ]
  2. Change From Baseline in Log HIV Viral Load at 48 Weeks [ Time Frame: Baseline and 48 weeks ]

Secondary Outcome Measures :
  1. Change From Baseline in Lipids at 48 Weeks [ Time Frame: Baseline and 48 weeks ]
  2. Change From Baseline in Interleukin-6 (IL-6) at 48 Weeks [ Time Frame: Baseline and 48 weeks ]
  3. Change From Baseline in Homocysteine at 6 Months [ Time Frame: Baseline and 48 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must be HIV-1 positive and naïve to HIV therapy.
  • Patients must plan to participate and be available for the trial for the 96-week study period.
  • Patients followed at Thomas Street Clinic.
  • Patients must be over 18 years old.

Exclusion Criteria:

  • Patients must not be pregnant or plan to become pregnant over the 96-week study period.
  • Patients cannot be on a proton pump inhibitor.
  • Patients cannot be undergoing treatment for active tuberculosis.
  • Renal Insufficiency with a creatinine clearance < 50 ml/min/1.73 m2 by the MDRD GFR calculation.
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00762892


Locations
United States, Texas
Thomas Street Clinic
Houston, Texas, United States, 77009
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Tanvir K Bell, MD UT-Houston
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
open access journal  This link exits the ClinicalTrials.gov site

Responsible Party: Tanvir K. Bell, MD, Associate Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT00762892     History of Changes
Other Study ID Numbers: raltegravir atazanavir naive
First Posted: September 30, 2008    Key Record Dates
Results First Posted: January 5, 2015
Last Update Posted: January 5, 2015
Last Verified: December 2014

Keywords provided by Tanvir K. Bell, MD, The University of Texas Health Science Center, Houston:
Raltegravir
Integrase inhibitor
Protease inhibitor
Naive patients
 HIV disease
Lipids
Treatment Naïve

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Tenofovir
Raltegravir Potassium
Emtricitabine
Atazanavir Sulfate
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Ritonavir
 Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents
HIV Integrase Inhibitors
Integrase Inhibitors
HIV Protease Inhibitors
Protease Inhibitors
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors