NCT00554398

Brief Summary

An intensification with the HIV-1 integrase inhibitor Raltegravir (RAL) of a stable HAART regimen with persistent HIV-1 viral suppression could increase the slope of decay of the HIV-1 latent reservoir.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at below P25 for phase_3 hiv-infections

Timeline
Completed

Started Nov 2007

Shorter than P25 for phase_3 hiv-infections

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

November 5, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 6, 2007

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

December 4, 2019

Status Verified

December 1, 2019

Enrollment Period

1.5 years

First QC Date

November 5, 2007

Last Update Submit

December 3, 2019

Conditions

HIV Infections

Keywords

RaltegravirMK-0518Treatment intensificationHIV-1 latencyHIV eradicationtreatment experienced

Outcome Measures

Primary Outcomes (1)

  • Quantification of integrated and unintegrated viral HIV-1 DNA in PBMCs

    Basal, week 12, week 24 and week 48

Secondary Outcomes (5)

  • Quantification of residual HIV-1 (using an ultrasensitive RT-PCR assay with a lower limit of quantification of 5 copies/mL)

    Basal, week 1, week 2, week 4, week 8, week 12, week 24, week 36 and week 48

  • Blips during the study (> 50 copies/mL, preceded and followed by determinations < 50 copies/mL in previous and posterior controls)

    Basal, week 4, week 8, week 12, week 24, week 36 and week 48

  • Lymphocyte activation marker CD8+HLADR+CD38+

    Basal, week 2, week 4, week 12, week 24 and week 48.

  • Raltegravir plasma trough concentration.

    Week 12, week 24 and week 48

  • Level of apoptosis in CD4 and CD8 T cells.

    Week 48 and week 60

Study Arms (2)

A

EXPERIMENTAL

MK-0518 400mg twice a day

Drug: MK-0518 400mg twice a day

B

NO INTERVENTION

No intervention

Interventions

MK-0518 400mg twice a dayDRUG

Raltegravir, MK-0518

Also known as: Raltegravir
A

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • HIV-1 infected adults (+18 years old).
  • Complete virological suppression (\<50 copies/mL) for += 12 months, including at least 3 times during the last year.
  • Patients on HAART regimen including a PI or an NNRTI and at least two nucleotide inhibitors.
  • Voluntary written informed consent.

You may not qualify if:

  • Pregnancy, or fertile women willing to be pregnant.
  • Active substance abuse or major psychiatric disease.
  • Presence of drug-related mutations or any polymorphism or mutation associated to MK-0518 resistance prior to first HAART (only if genotype is available).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hospital Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

Location

Hospital Clínic I Provinical de Barcelona

Barcelona, 08036, Spain

Location

Related Publications (1)

  • Llibre JM, Buzon MJ, Massanella M, Esteve A, Dahl V, Puertas MC, Domingo P, Gatell JM, Larrouse M, Gutierrez M, Palmer S, Stevenson M, Blanco J, Martinez-Picado J, Clotet B. Treatment intensification with raltegravir in subjects with sustained HIV-1 viraemia suppression: a randomized 48-week study. Antivir Ther. 2012;17(2):355-64. doi: 10.3851/IMP1917. Epub 2011 Sep 28.

    PMID: 22290239DERIVED

MeSH Terms

Conditions

HIV Infections

Interventions

Raltegravir Potassium

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

PyrrolidinonesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Martínez-Picado Javier, MD,PhD

    Irsi Caixa -Hospital Germans Trias i Pujol

    PRINCIPAL INVESTIGATOR

  • Paredes Roger, MD,PhD

    Lluita contra la Sida Foundation

    PRINCIPAL INVESTIGATOR

  • Clotet Bonaventura, MS,PhD

    Lluita contra la Sida Foundation

    PRINCIPAL INVESTIGATOR

  • Llibre Josep Mª, MD,PhD

    Lluita contra la SIDA Foundation

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2007

First Posted

November 6, 2007

Study Start

November 1, 2007

Primary Completion

May 1, 2009

Study Completion

September 1, 2009

Last Updated

December 4, 2019

Record last verified: 2019-12

Locations

ES(3)