Clinical Trials

MainTitle

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

This study has been completed
Sponsor
The University of Texas Health Science Center, Houston

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

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
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

Further study details as provided by Tanvir K. Bell, MD, 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 ]
  • Change From Baseline in Log HIV Viral Load at 48 Weeks [ Time Frame: Baseline and 48 weeks ]
Secondary Outcome Measures:
  • Change From Baseline in Lipids at 48 Weeks [ Time Frame: Baseline and 48 weeks ]
  • Change From Baseline in Interleukin-6 (IL-6) at 48 Weeks [ Time Frame: Baseline and 48 weeks ]
  • Change From Baseline in Homocysteine at 6 Months [ Time Frame: Baseline and 48 weeks ]

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

Eligibility

Ages Eligible for Study: 18 Years and older  
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

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

More Information

Additional Information:

open access journal

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  
Last Updated: December 19, 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
Tenofovir
Raltegravir Potassium
Emtricitabine
Atazanavir Sulfate
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Ritonavir

ClinicalTrials.gov processed this data on December 08, 2017
This information is provided by ClinicalTrials.gov.