Ignite Creation Date:
2025-12-17 @ 3:01 PM
Ignite Modification Date:
2025-12-23 @ 10:50 PM
Study NCT ID:
NCT00762892
Status:
COMPLETED
Last Update Posted:
2015-01-05
First Post:
2008-09-26
Is Possible Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Raltegravir vs. Atazanavir in Combination With Truvada® for the Treatment of Antiretroviral naïve HIV Infected Patients
Sponsor:
The University of Texas Health Science Center, Houston
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2014-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RAN
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: