Integrase Resistance Analysis in HIV Patients Who Interrupted Raltegravir Due to Incomplete Viral Suppression (RAL-dyn)

March 30, 2010 updated by: Hospital Clinic of Barcelona

Integrase Resistance Analysis in Treated Experienced HIV Patients Who Interrupted Raltegravir Due to Incomplete Viral Suppression

Prospective study to evaluate the potential persistent viral effect of raltegravir in 20 treatment experienced HIV patients with incomplete viral suppression

Study Overview

Status

Unknown

Conditions

HIV Infection

Intervention / Treatment

Drug: resume raltegravir

Study Type

Interventional

Enrollment (Anticipated)

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Spain
- - Barcelona, Spain, 08036
    - Recruiting
    - Hospital Clinic
    - Principal Investigator:
      
      Jose Luis Blanco, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult
Older Adult

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Subjects on Raltegravir-containing regimen with confirmed virological failure (VL >500c/mL for > 3 months).
Patients treated with a raltegravir-containing regimen for at least for 24 weeks.
CD4 cell count > 50 cell/mm3.
Adherence >90%, measured by short -self report questionnaire during the 3 months preceding the study entry.
No reasonable additional therapeutic options

Exclusion Criteria:

History or suspicion of alcohol or drug use which in the investigator's opinion would likely compromise subjects' safety and/or study procedures.
A positive urine drug test for amphetamines, cocaine and opioids at two consecutive screenings (a positive drug test at study screening will be repeated at baseline).
Life expectancy less than 6 months.
Subject has any currently active AIDS defining illness (Category C conditions according to the CDC Classification System for HIV Infection 1993) with the following 2 exceptions:
1. Stable cutaneous Kaposi's Sarcoma that is unlikely to require any form of systemic therapy during the study period.
2. Wasting syndrome due to HIV infection if, in the investigator's opinion, it is not actively progressive.
Any active clinically significant disease (e.g. TB, cardiac dysfunction) or findings during screening of medical history or physical examination that in the investigator's opinion, would compromise the outcome of the study.
Pregnant or breast-feeding female.
Renal impairment: serum creatinine > 2 x ULN.
Chronic Hepatitis B or C with ALT or AST > 3 x ULN.
Acute Hepatitis A, B or C. Acute Hepatitis A, B or C.
Any grade 3 or 4 toxicity according to the enhanced ACTG grading severity list, except for grade 3 or 4 asymptomatic triglyceride/cholesterol elevations, isolated grade 3 increased in GGT, grade 3 increases in glucose, asymptomatic grade 3 increases in amylase with no elevation of lipase.
Currently significant diarrhea, gastric stasis or constipation that in the investigator's opinion could influence drug absorption or bioavailability.
Subjects with clinical or laboratory evidence of significantly decreased hepatic function or decompensation, irrespective of liver enzyme levels (INR > 1.3 or albumin < 30g/l or bilirubin > 2.5 x ULN).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Screening
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in viral load after resuming raltegravir in patients with incomplete viral suppression with raltegravir. Time Frame: 24 weeks	24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Clinic of Barcelona

Investigators

Study Chair: Jose M Gatell, MD, Hospital Clinic of Barcelona

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Anticipated)

January 1, 2010

Study Completion (Anticipated)

January 1, 2010

Study Registration Dates

First Submitted

November 7, 2008

First Submitted That Met QC Criteria