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

This study has been completed.

Sponsor:

Collaborator:

Merck Sharp & Dohme Corp.

Information provided by (Responsible Party):

Tanvir K. Bell, MD, The University of Texas Health Science Center, Houston

ClinicalTrials.gov Identifier:

NCT00762892

First received: September 26, 2008

Last updated: December 19, 2014

Last verified: December 2014

History of Changes

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 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Emtricitabine Tenofovir Atazanavir Tenofovir Disoproxil Fumarate Atazanavir sulfate Raltegravir Truvada Raltegravir potassium

U.S. FDA Resources

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

Primary Outcome Measures:

Change From Baseline in CD4 Count at 48 Weeks [ Time Frame: Baseline and 48 weeks ] [ Designated as safety issue: No ]
Change From Baseline in Log HIV Viral Load at 48 Weeks [ Time Frame: Baseline and 48 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change From Baseline in Lipids at 48 Weeks [ Time Frame: Baseline and 48 weeks ] [ Designated as safety issue: Yes ]
Change From Baseline in Interleukin-6 (IL-6) at 48 Weeks [ Time Frame: Baseline and 48 weeks ] [ Designated as safety issue: No ]
Change From Baseline in Homocysteine at 6 Months [ Time Frame: Baseline and 48 weeks ] [ Designated as safety issue: No ]


Enrollment:	33
Study Start Date:	January 2009
Study Completion Date:	January 2013
Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:

open access journal This link exits the ClinicalTrials.gov site

No publications provided


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
Study First Received:	September 26, 2008
Results First Received:	December 19, 2014
Last Updated:	December 19, 2014
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

Additional relevant MeSH terms:


Atazanavir Emtricitabine Tenofovir Tenofovir disoproxil Anti-HIV Agents Anti-Infective Agents Anti-Retroviral Agents Antiviral Agents	Enzyme Inhibitors HIV Protease Inhibitors Molecular Mechanisms of Pharmacological Action Nucleic Acid Synthesis Inhibitors Pharmacologic Actions Protease Inhibitors Reverse Transcriptase Inhibitors Therapeutic Uses

ClinicalTrials.gov processed this record on February 27, 2015

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