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
Information obtained from ClinicalTrials.gov on December 08, 2011
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: Recruiting
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
Overall contact:
Tanvir K Bell, MD, Phone: 713-500-6767, Email: Tanvir.K.Bell@uth.tmc.edu
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 naïve HIV Infected Patients
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Cd4 count and HIV RNA viral load test
Secondary outcome: Lipids, safety labs, IL6, homocysteine
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
Tanvir K Bell, MD, Phone: 713-500-6767, Email: Tanvir.K.Bell@uth.tmc.edu
Thomas Street Clinic, Houston, Texas 77009, United States; Recruiting
Tanvir K Bell, MD, Phone: 713-500-6759, Email: Tanvir.K.Bell@uth.tmc.edu
Tanvir K Bell, MD, Principal Investigator
Roberto Arduino, MD, Sub-Investigator
Additional Information
Starting date: January 2009
Last updated: March 16, 2011
|
