Integrase Resistance Analysis in HIV Patients Who Interrupted Raltegravir Due to Incomplete Viral Suppression (RAL-dyn)
Verified March 2010
Hospital Clinic of Barcelona
Information provided by (Responsible Party)
Hospital Clinic of Barcelona
First received: November 7, 2008
Last updated: March 30, 2010
Last Verified: March 2010
History of Changes
Prospective study to evaluate the potential persistent viral effect of raltegravir in 20 treatment experienced HIV patients with incomplete viral suppression
Drug : resume raltegravir
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
|Official Title:||Integrase Resistance Analysis in Treated Experienced HIV Patients Who Interrupted Raltegravir Due to Incomplete Viral Suppression|
Further study details as provided by Hospital Clinic of Barcelona:
Primary Outcome Measures
- Change in viral load after resuming raltegravir in patients with incomplete viral suppression with raltegravir. [ Time Frame: 24 weeks ]
|Study Start Date:||November 2008|
|Estimated Study Completion Date:||January 2010|
|Estimated Primary Completion Date:||January 2010 (Final data collection date for primary outcome measure)|
|Ages Eligible for Study:||Child, Adult, Senior|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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
- 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
Contacts and LocationsChoosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00787774
Locations Show More
|Barcelona, Spain, 08036|
Principal Investigator: Jose Luis Blanco, MD
Sponsors and CollaboratorsHospital Clinic of Barcelona
|Study Chair:||Jose M Gatell, MD||Hospital Clinic of Barcelona|
|Responsible Party:||José Luis Blanco Arévalo, Hospital Clínic|
|ClinicalTrials.gov Identifier:||NCT00787774 History of Changes|
|Other Study ID Numbers:||RAL-dyn|
|Study First Received:||November 7, 2008|
|Last Updated:||March 30, 2010|
Keywords provided by Hospital Clinic of Barcelona:HIV
Additional relevant MeSH terms:
ClinicalTrials.gov processed this data on May 28, 2020
This information is provided by ClinicalTrials.gov.