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

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ClinicalTrials.gov Identifier: NCT01201239
Recruitment Status : Unknown
Verified September 2010 by Shanghai Public Health Clinical Center.
Recruitment status was:  Not yet recruiting
First Posted : September 14, 2010
Last Update Posted : September 14, 2010
Sponsor:
Information provided by:
Shanghai Public Health Clinical Center

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
HIV Drug: raltegravir Phase 4

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : September 2010
Estimated Primary Completion Date : May 2012
Estimated Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

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

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  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. [ Time Frame: 48 weeks ]

Secondary Outcome Measures :
  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 [ Time Frame: 48 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Hongzhou Lu, Shanghai Public Health Clinical Center
ClinicalTrials.gov Identifier: NCT01201239     History of Changes
Other Study ID Numbers: RAL-001
First Posted: September 14, 2010    Key Record Dates
Last Update Posted: September 14, 2010
Last Verified: September 2010

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

Additional relevant MeSH terms:
Raltegravir Potassium
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
 HIV Integrase Inhibitors
Integrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action