NCT00415090

Brief Summary

The purpose of this study is to evaluate the proportion of patients with viral load of HIV-1 \< 50 copies after 48 weeks of follow-up after randomization to change or not to nevirapine.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for phase_4 hiv-infections

Timeline
Completed

Started Aug 2004

Geographic Reach
1 country

17 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

August 1, 2004

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 19, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 22, 2006

Completed
Last Updated

October 31, 2008

Status Verified

October 1, 2008

Enrollment Period

1.9 years

First QC Date

December 19, 2006

Last Update Submit

October 30, 2008

Conditions

HIV Infections

Keywords

NevirapineAntiretroviral treatmentTriple nucleoside therapyHIVTreatment Experienced

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients with plasma viral load below 50 copies/mL .

    after 48 weeks of follow-up

Secondary Outcomes (6)

  • Time to the appearance of viral load >50 copies/mL in both branches (two consecutive determinations with 4-week separation between both).

    During the 48 weeks of follow-up.

  • Evolution of the CD4 lymphocyte count at 48 weeks.

    during 48 weeks of follow-up

  • Pattern of mutations associated with resistance in patients presenting virological failure.

    When there is a virological failure

  • Incidence of adverse clinical effects and laboratory alterations, giving rise or not to the withdrawal of the investigational treatment.

    during the 48 weeks of follow-up

  • Incidence of AIDS-defining events (CDC C events, 1993).

    during the 48 weeks of follow-up

  • +1 more secondary outcomes

Study Arms (2)

1

NO INTERVENTION

Follow with same ARV treatment

2

EXPERIMENTAL

Switch one of ARV drugs to Nevirapine

Drug: Nevirapine

Interventions

NevirapineDRUG

Switch one of ARV drugs to Nevirapine

Also known as: Switch one of ARV drugs to Nevirapine
2

Eligibility Criteria

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

You may qualify if:

  • Patients on triple treatment with 3 nucleoside analogues or transcriptase nucleotide inhibitors in virological suppression.
  • Age \>= 18 years.
  • Confirmed diagnosis of HIV-1 infection.
  • Viral load \< 50 copies/ml over the previous six months, including at least two consecutive determinations.
  • Value of ALT transaminase £ 2.5 times the normal value of the laboratory of each centre.
  • Acceptance and signature of the informed consent form.

You may not qualify if:

  • Pregnant women or those who intend to become pregnant in the study period.
  • Having had an active infection in the previous month.
  • Previous exposure to any reverse transcriptase non-nucleoside inhibitor (nevirapine, efavirenz or delavirdine).
  • Simultaneous treatment with methadone.
  • Patients with serious hepatic dysfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Hospital.Universitari Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

Centre Penitenciari Brians

Barcelona, Barcelona, 08009, Spain

Location

Hopsital de Sant Pau

Barcelona, Barcelona, 08025, Spain

Location

Hospital Vall d'Hebron

Barcelona, Barcelona, 08035, Spain

Location

Hospital Clínic i Provincial de Barcelona

Barcelona, Barcelona, 08036, Spain

Location

Hospital Sant Jaume de Calella

Barcelona, Barcelona, 08370, Spain

Location

Centre Penitenciari Homes

Barcelona, Barcelona, Spain

Location

Hospital General de Granollers

Granollers, Barcelona, 08400, Spain

Location

Centre Penitenciari Quatre Camins

Granollers, Barcelona, 08430, Spain

Location

Hospital de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Mutua de Terrassa

Terrassa, Barcelona, 08221, Spain

Location

Hospital La Candelaria

Santa Cruz de Tenerife, Canary Islands, 38010, Spain

Location

Hospital Clínico San Carlos de Madrid

Madrid, Madrid, 28040, Spain

Location

Hospital Universitari Sant Joan de Reus

Reus, Tarragona, 43201, Spain

Location

Hospital La Fe de Valencia

Valencia, Valencia, 46009, Spain

Location

Hospital Miguel Servet

Zaragoza, Zaragoza, 50009, Spain

Location

Hospital de Tortosa

Tortosa, 43500, Spain

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Nevirapine

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)

PyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Josep Mª Llibre, MD,PhD

    Hospital Sant Jaume de Calella

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 19, 2006

First Posted

December 22, 2006

Study Start

August 1, 2004

Primary Completion

July 1, 2006

Study Completion

July 1, 2006

Last Updated

October 31, 2008

Record last verified: 2008-10

Locations

ES(17)