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Raltegravir vs. Atazanavir in Combination With Truvada� for the Treatment of Antiretroviral na�ve HIV Infected Patients

Information source: The University of Texas Health Science Center, Houston
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV Infections

Intervention: Raltegravir and truvada (Drug); Atazanavir, Norvir and Truvada (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: The University of Texas Health Science Center, Houston

Official(s) and/or principal investigator(s):
Tanvir K Bell, MD, Principal Investigator, Affiliation: UT-Houston

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.

Clinical Details

Official title: A Pilot Study--randomized, Prospective, Single Site Trial Evaluating Raltegravir vs. Atazanavir in Combination With Truvada for the Treatment of Antiretroviral nave HIV Infected Patients

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Change From Baseline in CD4 Count at 48 Weeks

Change From Baseline in Log HIV Viral Load at 48 Weeks

Secondary outcome:

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

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Thomas Street Clinic, Houston, Texas 77009, United States
Additional Information

open access journal

Starting date: January 2009
Last updated: December 19, 2014

Page last updated: August 23, 2015

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