Text Size

Efficacy and Safety of Raltegravir (RAL) in Treatment-experienced HIV-1 Infected Adult Chinese Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Shanghai Public Health Clinical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Shanghai Public Health Clinical Center
ClinicalTrials.gov Identifier:
NCT01201239
First received: September 13, 2010
Last updated: NA
Last verified: September 2010
History: No changes posted
  Purpose

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.


Condition Intervention Phase
HIV
 Drug: raltegravir
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Pilot Study to Evaluate the Efficacy and Safety, Tolerability of Raltegravir（RAL）in Treatment-experienced HIV-1 Infected Adult Chinese Patients

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by Shanghai Public Health Clinical Center:

Primary Outcome Measures:
  • 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. [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: September 2010
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: raltegravir
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
RAL 400 mg twice daily plus OBT (optimized background therapy) for 48 weeks

  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:

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

Exclusion Criteria:

  • The patient is aged below 18 or over 65 years
  • The patient has serious opportunistic infections or tumors
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01201239

Locations
China, Shanghai
Shanghai Public Health Clinical Center Not yet recruiting
Shanghai, Shanghai, China, 201508
Sponsors and Collaborators
Shanghai Public Health Clinical Center
  More Information

No publications provided

Responsible Party: Hongzhou Lu, Shanghai Public Health Clinical Center
ClinicalTrials.gov Identifier: NCT01201239     History of Changes
Other Study ID Numbers: RAL-001
Study First Received: September 13, 2010
Last Updated: September 13, 2010
Health Authority: China: State Food and Drug Administration

Keywords provided by Shanghai Public Health Clinical Center:
raltegravir
HIV-1
drug resistance

ClinicalTrials.gov processed this record on March 03, 2013