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

NCT ID: NCT00787774

Last Updated: 2010-03-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2010-01-31

Brief Summary

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

Conditions

HIV Infection

Keywords

HIV; resistance; integrase

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Interventions

resume raltegravir

resume raltegravir after 16 weeks of stopping

Intervention Type: DRUG

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).

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Clinic of Barcelona

OTHER

Sponsor Role: lead

Responsible Party

Hospital Clínic

Principal Investigators

Jose M Gatell, MD

Role: STUDY_CHAIR

Hospital Clinic of Barcelona

Locations

Hospital Clinic

Barcelona, Barcelona, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Jose Luis Blanco, MD

Role: CONTACT

Phone: +34932275400

Other Identifiers

RAL-dyn

Identifier Type: -

Identifier Source: org_study_id