NCT00324688

Brief Summary

This study looks at HIV-infected subjects who are on methadone treatment and medicines for HIV.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for phase_4 hiv-infections

Timeline
Completed

Started Mar 2003

Typical duration for phase_4 hiv-infections

Geographic Reach
1 country

1 active site

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

March 1, 2003

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

May 10, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 11, 2006

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
Last Updated

March 12, 2014

Status Verified

March 1, 2014

First QC Date

May 10, 2006

Last Update Submit

March 11, 2014

Conditions

HIV Infections

Keywords

HIV-1MethadoneHIV-1 infection

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients with HIV RNA < 400 and with HIV RNA < 50 copies/mL at Week 48

Secondary Outcomes (13)

  • Proportion of patients with HIV RNA < 400 and with HIV RNA < 50 copies/mL at Week 24

  • Time to failure or ART discontinuation. Virological failure is defined as 2 consecutive measurements 4 weeks apart with viral load of HIV RNA > 400 copies/mL

  • Adherence to HIV treatments (Medication Adherence Self-Report Inventory [MASRI] questionnaire, monthly evaluation through patient diary)

  • Adherence to opiate substitution treatment

  • Correlation of adherence to ART and HIV RNA levels

  • +8 more secondary outcomes

Interventions

VireadDRUG

Eligibility Criteria

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

You may qualify if:

  • Ages 18 years or older
  • Previously documented diagnosis of HIV-1 infection:
  • by antibody assay (enzyme immunoassay confirmed by western immunoblot); or
  • positive HIV culture; or
  • detectable plasma HIV-1-RNA levels by reverse transcriptase polymerase chain reaction (RT-PCR).
  • Receiving stable opiate substitution (stable methadone level for ≥ 2 weeks prior to entry into the study) with methadone, levomethadone or buprenorphine
  • Either:
  • Antiretroviral (ARV) therapy-naïve(\*) and with:
  • CD4 counts \< 351 cells/µL; and/or
  • HIV-1 plasma levels \>= 30,000 copies/mL (\*)less than 3 months of ART for vertical transmission is considered as ARV therapy naïve.
  • Or restarting ART after treatment discontinuation with no evidence of prior HIV virological failure (virological failure defined as 2 consecutive measurements 4 weeks apart with viral load of HIV RNA \> 400 copies/mL while on ART)
  • Or currently receiving stable ART therapy and with virological suppression (\< 400 copies/mL), for at least 6 months and:
  • suffering from adherence problems because of dosing of current ART; or
  • suffering from side effects on the current recorded ART.
  • Able to give informed consent
  • +1 more criteria

You may not qualify if:

  • Need for antiretroviral therapy which is not according to protocol
  • Pregnant or breastfeeding women
  • Females of childbearing potential not willing to use a barrier method(s) of contraception during heterosexual intercourse during the duration of the study
  • Contraindication to use of tenofovir DF 300 mg or another concomitant medication
  • Known hypersensitivity to the active component or excipients
  • Prior receipt of tenofovir
  • Evidence of clinical, genotypic, or phenotypic resistance to any ARV
  • History of virological failure while on previously recorded ART regimens (virological failure defined as 2 consecutive measurements 4 weeks apart with viral load of HIV RNA \> 400 copies/mL)
  • Acute, life-threatening infection or malignancy that needs systemic therapy
  • Any clinical laboratory findings obtained during screening that could be a risk factor for the patient during the study:
  • Grade 4 increase of any laboratory value
  • Grade 3 (\> 5-10 upper limit of normal \[ULN\] increase in transaminases) at the screening visit
  • Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study or unable to comply with the study requirements.
  • Current use of medication that, in the investigator's opinion or sponsor's opinion, will interfere with the study medication
  • Participation in other clinical trials
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gilead Sciences

Munich, Germany

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Tenofovir

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)

OrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsAdeninePurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Thomas Mertenskoetter

    Gilead Sciences

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 10, 2006

First Posted

May 11, 2006

Study Start

March 1, 2003

Study Completion

June 1, 2006

Last Updated

March 12, 2014

Record last verified: 2014-03

Locations

DE(1)