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

NCT ID: NCT00762892

Last Updated: 2015-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2013-01-31

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.

Conditions

HIV Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Raltegravir

Raltegravir in combination with truvada (tenofovir and emtricitabine)

Group Type: ACTIVE_COMPARATOR

Raltegravir and truvada

Intervention Type: DRUG

Raltegravir 400 mg po bid, truvada 1 tab q daily

Atazanavir

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

Group Type: ACTIVE_COMPARATOR

Atazanavir, Norvir and Truvada

Intervention Type: DRUG

Atazanavir 300 mg po q daily, Norvir 100 mg po q daily and Truvada 1 tablet po q daily

Interventions

Raltegravir and truvada

Raltegravir 400 mg po bid, truvada 1 tab q daily

Intervention Type: DRUG

Atazanavir, Norvir and Truvada

Atazanavir 300 mg po q daily, Norvir 100 mg po q daily and Truvada 1 tablet po q daily

Intervention Type: DRUG

Other Intervention Names

Truvada is tenofovir 300 mg and emtricitabine 200 mg; Truvada is tenofovir 300 mg and emtricitabine 200 mg

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: lead

Responsible Party

Tanvir K. Bell, MD

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tanvir K Bell, MD

Role: PRINCIPAL_INVESTIGATOR

UT-Houston

Locations

Thomas Street Clinic

Houston, Texas, United States

Countries

United States

Related Links

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

open access journal

Other Identifiers

raltegravir atazanavir naive

Identifier Type: -

Identifier Source: org_study_id