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

HIV Infection Clinical Trial

— RAL-dyn  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00787774
• Other study ID #: RAL-dyn
• Status: Recruiting
• Phase: N/A
• First received: November 7, 2008
• Last updated: March 30, 2010
• Start date: November 2008
• Est. completion date: January 2010

Study information

• Verified date: March 2010
• Source: Hospital Clinic of Barcelona
• Contact: Jose Luis Blanco, MD
• Phone: +34932275400
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• HIV Infection

Intervention

Drug:
• resume raltegravir
resume raltegravir after 16 weeks of stopping

Locations

Country	Name	City	State
Spain	Hospital Clinic	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in viral load after resuming raltegravir in patients with incomplete viral suppression with raltegravir.		24 weeks	No