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

The University of Texas System (UT)

Status and phase

Completed

Phase 4

Conditions

HIV Infections

Treatments

Drug: Atazanavir, Norvir and Truvada

Drug: Raltegravir and truvada

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00762892

raltegravir atazanavir naive

Details and patient eligibility

About

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.

Full 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.

Enrollment

33 patients

Sex

All

Ages

18+ years old

Volunteers

No 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.