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Clinical Trials

MainTitle

Integrase Resistance Analysis in HIV Patients Who Interrupted Raltegravir Due to Incomplete Viral Suppression (RAL-dyn)

The recruitment status of this study is unknown.

Verified March 2010

Sponsor
Hospital Clinic of Barcelona


Information provided by (Responsible Party)
Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier
NCT00787774

First received: November 7, 2008
Last updated: March 30, 2010
Last Verified: March 2010
History of Changes
Purpose

Purpose

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

Condition Intervention
HIV Infection

Drug : resume raltegravir

Study Type: Interventional
Study Design: 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 ]

Estimated Enrollment: 20
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)

Eligibility

Eligibility

Ages Eligible for Study: Child, Adult, Senior  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

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).

contacts and locations

Contacts and Locations

Choosing 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

Contacts

Contact:   Jose Luis Blanco, MD +34932275400 ext 3311

Locations

Spain
Hospital Clinic Recruiting
Barcelona, Spain, 08036
Principal Investigator: Jose Luis Blanco, MD

Sponsors and Collaborators

Hospital Clinic of Barcelona

Investigators

Study Chair: Jose M Gatell, MD Hospital Clinic of Barcelona
More Information

More Information


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
resistance
integrase

Additional relevant MeSH terms:
HIV Infections
Raltegravir Potassium

ClinicalTrials.gov processed this data on October 23, 2017
This information is provided by ClinicalTrials.gov.