Raltegravir vs. Atazanavir in Combination With Truvada® for the Treatment of Antiretroviral naïve HIV Infected Patients - Full Text View

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

This study is currently recruiting participants.

Verified by The University of Texas Health Science Center, Houston, September 2009

First Received: September 26, 2008 Last Updated: September 4, 2009 History of Changes

Sponsors and Collaborators:	The University of Texas Health Science Center, Houston Merck
Information provided by:	The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:	NCT00762892

Purpose

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	Intervention	Phase
HIV Infections	Drug: Raltegravir and truvada Drug: Atazanavir, Norvir and Truvada	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: AIDS

Drug Information available for: Tenofovir Ritonavir BMS 232632 Atazanavir sulfate Raltegravir Truvada

U.S. FDA Resources

Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:

Cd4 count and HIV RNA viral load test [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Lipids, safety labs, IL6, homocysteine [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	40
Study Start Date:	January 2009
Estimated Study Completion Date:	June 2011
Estimated Primary Completion Date:	May 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Raltegravir: Active Comparator Raltegravir in combination with truvada (tenofovir and emtricitabine)	Drug: Raltegravir and truvada Raltegravir 400 mg po bid, truvada 1 tab q daily
Atazanavir: Active Comparator 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

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00762892

Contacts

Contact: Tanvir K Bell, MD

713-500-6767

Tanvir.K.Bell@uth.tmc.edu

Locations

United States, Texas
Thomas Street Clinic	Recruiting
Houston, Texas, United States, 77009
Contact: Tanvir K Bell, MD 713-500-6759 Tanvir.K.Bell@uth.tmc.edu
Principal Investigator: Tanvir K Bell, MD
Sub-Investigator: Roberto Arduino, MD

Sponsors and Collaborators

The University of Texas Health Science Center, Houston

Merck

Investigators

Principal Investigator:

Tanvir K Bell, MD

UT-Houston

More Information

No publications provided

Responsible Party:	UT-Houston ( Tanvir Bell, MD )
Study ID Numbers:	raltegravir atazanavir naive
Study First Received:	September 26, 2008
Last Updated:	September 4, 2009
ClinicalTrials.gov Identifier:	NCT00762892 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center, Houston:

Raltegravir
Integrase inhibitor
Protease inhibitor
Naive patients

HIV disease
Lipids
Treatment Naïve

Study placed in the following topic categories:

Anti-Infective Agents
HIV Protease Inhibitors
Sexually Transmitted Diseases, Viral
Anti-HIV Agents
Acquired Immunodeficiency Syndrome
Atazanavir
Antiviral Agents
Immunologic Deficiency Syndromes
Protease Inhibitors
Virus Diseases

Anti-Retroviral Agents
Emtricitabine
Integrase Inhibitors
HIV Infections
Ritonavir
Sexually Transmitted Diseases
Tenofovir
Retroviridae Infections
Tenofovir disoproxil

Additional relevant MeSH terms:

Anti-Infective Agents
HIV Protease Inhibitors
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Anti-HIV Agents
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Atazanavir
Infection

Antiviral Agents
Pharmacologic Actions
Immunologic Deficiency Syndromes
Protease Inhibitors
Virus Diseases
Anti-Retroviral Agents
Emtricitabine
HIV Infections
Therapeutic Uses
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections

ClinicalTrials.gov processed this record on September 11, 2009