Phase 4 N=28 Randomized Treatment

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

HIV Infections

Bottom Line

View on ClinicalTrials.gov: NCT00762892 ↗

Enrolled (actual)

Serious AEs

3.6%

Results posted

Jan 2015

Primary outcome: Primary: Change From Baseline in CD4 Count at 48 Weeks — 192; 205 cells/uL

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Raltegravir and truvada (Drug); Atazanavir, Norvir and Truvada (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: The University of Texas Health Science Center, Houston
Primary completion: Dec 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in CD4 Count at 48 Weeks	192; 205	—
PRIMARY Change From Baseline in Log HIV Viral Load at 48 Weeks	-3.05; -3.29	—
SECONDARY Change From Baseline in Lipids at 48 Weeks	-0.25; 8.13; -15.50; 16.88; -1.5; -1.38	—
SECONDARY Change From Baseline in Interleukin-6 (IL-6) at 48 Weeks	-2.71; -4.47	—
SECONDARY Change From Baseline in Homocysteine at 6 Months	0.53; 0.10	—

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.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00762892). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.