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

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Raltegravir and truvada
Atazanavir, Norvir and Truvada
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Raltegravir, Integrase inhibitor, Protease inhibitor, Naive patients, HIV disease, Lipids, Treatment Naïve

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Thomas Street Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Raltegravir

Atazanavir

Arm Description

Raltegravir in combination with truvada (tenofovir and emtricitabine)

Atazanavir, low dose ritonavir, and truvada (tenofovir and emtricitabine)

Outcomes

Primary Outcome Measures

Change From Baseline in CD4 Count at 48 Weeks
Change From Baseline in Log HIV Viral Load at 48 Weeks

Secondary Outcome Measures

Change From Baseline in Lipids at 48 Weeks
Change From Baseline in Interleukin-6 (IL-6) at 48 Weeks
Change From Baseline in Homocysteine at 6 Months

Full Information

First Posted
September 26, 2008
Last Updated
December 19, 2014
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00762892
Brief Title
Raltegravir vs. Atazanavir in Combination With Truvada® for the Treatment of Antiretroviral naïve HIV Infected Patients
Acronym
RAN
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 Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Raltegravir, Integrase inhibitor, Protease inhibitor, Naive patients, HIV disease, Lipids, Treatment Naïve

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Raltegravir
Arm Type
Active Comparator
Arm Description
Raltegravir in combination with truvada (tenofovir and emtricitabine)
Arm Title
Atazanavir
Arm Type
Active Comparator
Arm Description
Atazanavir, low dose ritonavir, and truvada (tenofovir and emtricitabine)
Intervention Type
Drug
Intervention Name(s)
Raltegravir and truvada
Other Intervention Name(s)
Truvada is tenofovir 300 mg and emtricitabine 200 mg
Intervention Description
Raltegravir 400 mg po bid, truvada 1 tab q daily
Intervention Type
Drug
Intervention Name(s)
Atazanavir, Norvir and Truvada
Other Intervention Name(s)
Truvada is tenofovir 300 mg and emtricitabine 200 mg
Intervention Description
Atazanavir 300 mg po q daily, Norvir 100 mg po q daily and Truvada 1 tablet po q daily
Primary Outcome Measure Information:
Title
Change From Baseline in CD4 Count at 48 Weeks
Time Frame
Baseline and 48 weeks
Title
Change From Baseline in Log HIV Viral Load at 48 Weeks
Time Frame
Baseline and 48 weeks
Secondary Outcome Measure Information:
Title
Change From Baseline in Lipids at 48 Weeks
Time Frame
Baseline and 48 weeks
Title
Change From Baseline in Interleukin-6 (IL-6) at 48 Weeks
Time Frame
Baseline and 48 weeks
Title
Change From Baseline in Homocysteine at 6 Months
Time Frame
Baseline and 48 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tanvir K Bell, MD
Organizational Affiliation
UT-Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thomas Street Clinic
City
Houston
State/Province
Texas
ZIP/Postal Code
77009
Country
United States

12. IPD Sharing Statement

Links:
URL
http://omicsonline.org/lipid-and-biomarker-differences-between-raltegravir-and-atazanavir-ritonavir-at-48-weeks-in-the-raltegravir-atazanavir-2155-6113.1000192.php?aid=11665
Description
open access journal

Learn more about this trial

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

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