Clinical trial NCT00787774: Integrase Resistance Analysis in HIV Patients Who Interrupted Raltegravir Due to Incomplete Viral Suppression
Official title: Integrase Resistance Analysis in Treated Experienced HIV Patients Who Interrupted Raltegravir Due to Incomplete Viral Suppression
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: HIV Infection
Keywords: HIV
resistance
integrase
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2008-11-10
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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 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).

Primary outcomes:
measure: Change in viral load after resuming raltegravir in patients with incomplete viral suppression with raltegravir.
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic
Study officials:
affiliation: Hospital Clinic of Barcelona
name: Jose M Gatell, MD
role: STUDY_CHAIR
References: