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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2010 by Hospital Clinic of Barcelona.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00787774
First Posted: November 10, 2008
Last Update Posted: March 31, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hospital Clinic of Barcelona
November 7, 2008
November 10, 2008
March 31, 2010
November 2008
January 2010   (Final data collection date for primary outcome measure)
Change in viral load after resuming raltegravir in patients with incomplete viral suppression with raltegravir. [ Time Frame: 24 weeks ]
Same as current
Complete list of historical versions of study NCT00787774 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Integrase Resistance Analysis in HIV Patients Who Interrupted Raltegravir Due to Incomplete Viral Suppression
Integrase Resistance Analysis in Treated Experienced HIV Patients Who Interrupted Raltegravir Due to Incomplete Viral Suppression
Prospective study to evaluate the potential persistent viral effect of raltegravir in 20 treatment experienced HIV patients with incomplete viral suppression
Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
HIV Infection
Drug: resume raltegravir
resume raltegravir after 16 weeks of stopping
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
20
January 2010
January 2010   (Final data collection date for primary outcome measure)

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).
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
 
NCT00787774
RAL-dyn
No
Not Provided
Not Provided
José Luis Blanco Arévalo, Hospital Clínic
Hospital Clinic of Barcelona
Not Provided
Study Chair: Jose M Gatell, MD Hospital Clinic of Barcelona
Hospital Clinic of Barcelona
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP