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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 because the information has not been verified recently.
Verified March 2010 by Hospital Clinic of Barcelona.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT00787774
First received: November 7, 2008
Last updated: March 30, 2010
Last verified: March 2010

November 7, 2008
March 30, 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 ] [ Designated as safety issue: No ]
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: 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.
 
Recruiting
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).
Both
Not Provided
No
Contact: Jose Luis Blanco, MD +34932275400 ext 3311
Spain
 
NCT00787774
RAL-dyn
No
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