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

HIV Infections Clinical Trial

— RAN  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00762892
• Other study ID #: raltegravir atazanavir naive
• Status: Completed
• Phase: Phase 4
• First received: September 26, 2008
• Last updated: December 19, 2014
• Start date: January 2009
• Est. completion date: January 2013

Study information

• Verified date: December 2014
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: January 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Raltegravir and truvada
Raltegravir 400 mg po bid, truvada 1 tab q daily
• Atazanavir, Norvir and Truvada
Atazanavir 300 mg po q daily, Norvir 100 mg po q daily and Truvada 1 tablet po q daily

Locations

Country	Name	City	State
United States	Thomas Street Clinic	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in CD4 Count at 48 Weeks		Baseline and 48 weeks	No
Primary	Change From Baseline in Log HIV Viral Load at 48 Weeks		Baseline and 48 weeks	No
Secondary	Change From Baseline in Lipids at 48 Weeks		Baseline and 48 weeks	Yes
Secondary	Change From Baseline in Interleukin-6 (IL-6) at 48 Weeks		Baseline and 48 weeks	No
Secondary	Change From Baseline in Homocysteine at 6 Months		Baseline and 48 weeks	No

External Links

•   open access journal