Trial record 9 of 34 for:    " October 08, 2008":" November 07, 2008"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

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
  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: Open Label
Primary Purpose: Screening
Official Title: Integrase Resistance Analysis in Treated Experienced HIV Patients Who Interrupted Raltegravir Due to Incomplete Viral Suppression

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]

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)
Intervention Details:
    Drug: resume raltegravir
    resume raltegravir after 16 weeks of stopping
  Eligibility

Genders Eligible for Study:   Both
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
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

No publications provided

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
Health Authority: Spain: Ethics Committee

Keywords provided by Hospital Clinic of Barcelona:
HIV
resistance
integrase

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on July 26, 2014