Status:
UNKNOWN
Integrase Resistance Analysis in HIV Patients Who Interrupted Raltegravir Due to Incomplete Viral Suppression
Lead Sponsor:
Hospital Clinic of Barcelona
Conditions:
HIV Infection
Eligibility:
All Genders
Phase:
NA
Brief Summary
Prospective study to evaluate the potential persistent viral effect of raltegravir in 20 treatment experienced HIV patients with incomplete viral suppression
Eligibility Criteria
Inclusion
- 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
- 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:
- Stable cutaneous Kaposi's Sarcoma that is unlikely to require any form of systemic therapy during the study period.
- 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).
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2010
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00787774
Start Date
November 1 2008
End Date
January 1 2010
Last Update
March 31 2010
Active Locations (1)
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1
Hospital Clinic
Barcelona, Barcelona, Spain, 08036