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
Overview
- Phase
- Phase 4
- Intervention
- Raltegravir and truvada
- Conditions
- HIV Infections
- Sponsor
- The University of Texas Health Science Center, Houston
- Enrollment
- 33
- Locations
- 1
- Primary Endpoint
- Change From Baseline in Log HIV Viral Load at 48 Weeks
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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.
Investigators
Tanvir K. Bell, MD
Associate Professor
The University of Texas Health Science Center, Houston
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.
Arms & Interventions
Raltegravir
Raltegravir in combination with truvada (tenofovir and emtricitabine)
Intervention: Raltegravir and truvada
Atazanavir
Atazanavir, low dose ritonavir, and truvada (tenofovir and emtricitabine)
Intervention: Atazanavir, Norvir and Truvada
Outcomes
Primary Outcomes
Change From Baseline in Log HIV Viral Load at 48 Weeks
Time Frame: Baseline and 48 weeks
Change From Baseline in CD4 Count at 48 Weeks
Time Frame: Baseline and 48 weeks
Secondary Outcomes
- Change From Baseline in Interleukin-6 (IL-6) at 48 Weeks(Baseline and 48 weeks)
- Change From Baseline in Homocysteine at 6 Months(Baseline and 48 weeks)
- Change From Baseline in Lipids at 48 Weeks(Baseline and 48 weeks)