Trial record 8 of 29 for:    " November 21, 2011":" December 21, 2011"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

Impact of Raltegravir Intensification on HIV-1-infected Subjects With Complete Viral Suppression Under Monotherapy With Protease Inhibitors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
IrsiCaixa
ClinicalTrials.gov Identifier:
NCT01480713
First received: November 21, 2011
Last updated: June 27, 2014
Last verified: June 2014
  Purpose

This is a pilot, proof of concept, open-label clinical trial, to assess the extend of persistent viral reservoir and the level of immune activation in patients receiving suppressive treatment with protease inhibitors.

40 Chronically HIV-1 infected subjects, receiving monotherapy with ritonavir-boosted lopinavir or darunavir for at least 12 months with plasma viremia below 50 copies HIV RNA per ml, and CD4 T-cell counts greater than 500 cells/mm3 will be included.

The total duration of the study will be 48 weeks: 12 weeks for patients' inclusion, 24 weeks of follow-up once the last patient is included, and 12 weeks for data analysis.


Condition Intervention Phase
HIV-1 Infection
Drug: Isentress® (Raltegravir, 400 mg every 12 hours)
Drug: Isentress® (Raltegravir, 400 every 12 hours)
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Impact of Raltegravir Intensification on HIV-1-infected Subjects With Complete Viral Suppression Under Monotherapy With Protease Inhibitors. A 24-week Open-label, Proof-of-concept Pilot Clinical Trial.

Resource links provided by NLM:


Further study details as provided by IrsiCaixa:

Primary Outcome Measures:
  • Change from week -8 in Integrated viral HIV-1 DNA in A peripheral blood mononuclear cells (PBMCs) at 8 months. [ Time Frame: week -8, -4, Baseline, week 4, 12 and 24 ] [ Designated as safety issue: No ]
  • Change from week -8 in Unintegrated viral HIV-1 DNA in PBMCs at 8 months. [ Time Frame: week -8, -4, Baseline, week 1, 2, 4, 8, 12 and 24 ] [ Designated as safety issue: No ]
  • Change from week -8 in lymphocyte activation markers in PBMCs at 8 months. [ Time Frame: week -8, -4, Baseline, week 4, 8, 12 and 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • ultrasensitive HIV-1 viral load [ Time Frame: week -8, -4, Baseline, week 1, 2, 4, 8, 12 and 24 ] [ Designated as safety issue: No ]
  • viral load >50 copies/mL [ Time Frame: week -8, -4, Baseline, week 1, 2, 4, 8, 12 and 24 ] [ Designated as safety issue: No ]
  • HIV-1 RNA below 50 copies/mL. [ Time Frame: week 24 and 48 ] [ Designated as safety issue: No ]
  • Change in the lymphocyte activation markers [ Time Frame: week -8, -4, Baseline, week 1, 2, 4, 8, 12, and 24 and 48. ] [ Designated as safety issue: No ]
  • Change in the inflammation markers (soluble CD14, IL-6, D-Dimer, vCam, C Reactive Protein) [ Time Frame: week -8, -4, Baseline, week 4, 8, 12, and 24 and 48 ] [ Designated as safety issue: Yes ]

Enrollment: 41
Study Start Date: May 2012
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Monotherapy with IPs+ Raltegravir 400 mg
Lopinavir/r 400/100 mg every 12 hours + Raltegravir 400 mg every 12 hours or Darunavir/rit 800/100 mg every 24 hours + Raltegravir 400 mg every 12 hours
Drug: Isentress® (Raltegravir, 400 mg every 12 hours)
Lopinavir/r 200/50 mg every 12 hours + Raltegravir 400 mg every 12 hours
Other Name: N/H
Drug: Isentress® (Raltegravir, 400 every 12 hours)
Darunavir/rit 800/100 mg every 24 hours + Raltegravir 400 mg every 12 hours
Other Name: N/H

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. HIV-1 infected adults (≥18 years old).
  2. Absence of prior virological failure with protease inhibitors (PIs).
  3. No mono or dual protease inhibitor therapy previous to HAART initiation.
  4. Patients had to be on monotherapy with ritonavir-boosted lopinavir (LPV/r 400/100 mg every 12 hours) or darunavir (DRV/r 800/100 mg every 24 hours) for ≥ 12 months. Switching from standard HAART to protease inhibitor monotherapy had to happen with undetectable plasma viremia.
  5. Complete virological suppression (<50 copies/mL) for ≥12 months, including at least 2 times during the last year.
  6. CD4 cell count ≥500 cells/µL.
  7. Availability (if possible, not mandatory) of a genotype prior to the start of HAART, with absence of any major drug-related mutations.
  8. Voluntary written informed consent.

Exclusion Criteria:

  1. Lactating, pregnancy, or fertile women willing to be pregnant.
  2. Active substance abuse or major psychiatric disease.
  3. Presence of any polymorphism or mutation associated to raltegravir resistance at baseline (prior to first HAART).
  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: NCT01480713

Locations
Spain
Germans Trias i Pujol Hospital
Badalona, Barcelona, Spain, 08916
Sponsors and Collaborators
IrsiCaixa
  More Information

No publications provided

Responsible Party: IrsiCaixa
ClinicalTrials.gov Identifier: NCT01480713     History of Changes
Other Study ID Numbers: RIPIM, 2011-004464-30
Study First Received: November 21, 2011
Last Updated: June 27, 2014
Health Authority: Spain: Ministry of Health

Keywords provided by IrsiCaixa:
HIV-1
protease inhibitors
integrase inhibitors
raltegravir
viral replication
treatment intensification
viral pathogenesis
immune activation

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
Protease Inhibitors
HIV Protease Inhibitors
Integrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014