NCT01201239

Brief Summary

To assess the safety, tolerability and efficacy of Raltegravir (RAL) when combined with other antiretroviral drugs in treatment-experienced Chinese HIV-infected patients, including those with multi-drug resistant HIV-1 infection or drug intolerance.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_4 hiv

Timeline
Completed

Started Sep 2010

Geographic Reach
1 country

1 active site

Status
unknown

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

September 1, 2010

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

September 13, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 14, 2010

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

September 14, 2010

Status Verified

September 1, 2010

Enrollment Period

1.7 years

First QC Date

September 13, 2010

Last Update Submit

September 13, 2010

Conditions

HIV

Keywords

raltegravirHIV-1drug resistance

Outcome Measures

Primary Outcomes (1)

  • the safety and tolerability of RAL 400 mg b.i.d. in combination with optimized background therapy (OBT), assessed by review of the accumulated safety data in HIV-infected adult patients.

    48 weeks

Secondary Outcomes (1)

  • antiretroviral activity of RAL 400 mg b.i.d. in combination with OBT as measured by change at week 24 in viral load from baseline, increase of CD4+ T lymphocytes compared to baseline

    48 weeks

Study Arms (1)

raltegravir

EXPERIMENTAL

HIV-infected patients aged over 18 who have failed previous antiretroviral treatment with multi-drug resistant or with multi-drug intolerance are to accept Ral plus OBT.

Drug: raltegravir

Interventions

raltegravirDRUG

RAL 400 mg twice daily plus OBT (optimized background therapy) for 48 weeks

raltegravir

Eligibility Criteria

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

You may qualify if:

  • HIV-infected patients aged over 18 who have failed previous antiretroviral treatment with multi-drug resistant or with multi-drug intolerance

You may not qualify if:

  • The patient is aged below 18 or over 65 years
  • The patient has serious opportunistic infections or tumors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Public Health Clinical Center

Shanghai, Shanghai Municipality, 201508, China

Location

MeSH Terms

Interventions

Raltegravir Potassium

Intervention Hierarchy (Ancestors)

PyrrolidinonesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

September 13, 2010

First Posted

September 14, 2010

Study Start

September 1, 2010

Primary Completion

May 1, 2012

Study Completion

October 1, 2012

Last Updated

September 14, 2010

Record last verified: 2010-09

Locations

CN(1)