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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00787774
• Date of registration: 07/11/2008
• Prospective Registration: No
• Primary sponsor: Hospital Clinic of Barcelona
• Public title: Integrase Resistance Analysis in HIV Patients Who Interrupted Raltegravir Due to Incomplete Viral Suppression RAL-dyn
• Scientific title: Integrase Resistance Analysis in Treated Experienced HIV Patients Who Interrupted Raltegravir Due to Incomplete Viral Suppression
• Date of first enrolment: November 2008
• Target sample size: 20
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT00787774
• Study type: Interventional
• Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening
• Phase: N/A

Countries of recruitment

Spain

Contacts

• Name: Jose Luis Blanco, MD

• Name: Jose M Gatell, MD
• Affiliation: Hospital Clinic of Barcelona

Key inclusion & exclusion 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).



Age minimum: N/A
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

HIV Infection

Intervention(s)

Drug: resume raltegravir

Primary Outcome(s)

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

Secondary ID(s)

RAL-dyn

Source(s) of Monetary Support

Please refer to primary and secondary sponsors