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

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. Identifier: NCT00787774
Recruitment Status : Unknown
Verified March 2010 by Hospital Clinic of Barcelona.
Recruitment status was:  Recruiting
First Posted : November 10, 2008
Last Update Posted : March 31, 2010
Information provided by:
Hospital Clinic of Barcelona

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

Condition or disease Intervention/treatment Phase
HIV Infection Drug: resume raltegravir Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
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
Study Start Date : November 2008
Estimated Primary Completion Date : January 2010
Estimated Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Intervention Details:
  • Drug: resume raltegravir
    resume raltegravir after 16 weeks of stopping

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

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

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00787774

Contact: Jose Luis Blanco, MD +34932275400 ext 3311

Hospital Clinic Recruiting
Barcelona, Spain, 08036
Principal Investigator: Jose Luis Blanco, MD         
Sponsors and Collaborators
Hospital Clinic of Barcelona
Study Chair: Jose M Gatell, MD Hospital Clinic of Barcelona

Responsible Party: José Luis Blanco Arévalo, Hospital Clínic Identifier: NCT00787774     History of Changes
Other Study ID Numbers: RAL-dyn
First Posted: November 10, 2008    Key Record Dates
Last Update Posted: March 31, 2010
Last Verified: March 2010

Keywords provided by Hospital Clinic of Barcelona:

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Raltegravir Potassium
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
HIV Integrase Inhibitors
Integrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action