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:


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

  Hide Detailed Description

Detailed Description:

An open, prospective, uncontrolled pilot study to evaluate the efficacy and safety of raltegravir in treatment-experienced HIV-1 infected adult patients who have failed the previous antiretroviral treatment due to drug resistance or drug intolerance.

  1. Patients Enrollment:

    HIV-infected patients aged over 18 who have failed previous antiretroviral treatment with multi-drug resistant or with multi-drug intolerance are eligible. And at least 50 subjects are to be concluded in the trial.

    ⅰ) The diagnostic criteria of HIV/AIDS refer to guidelines for diagnosis and treatment of HIV/AIDS in China(2005).

    ⅱ) Treatment failure will be defined as follows: (i): HIV viral load has decreased by less than 1 log copies/ml in patients with 8 weeks of HAART, or (ii) HIV viral load is still detectable after 6 months of HAART;or (iii) reappearance of a detectable viral load after HAART has led to undetectable viral load.

    ⅲ) The definition of drug resistance is based on a genotypic resistance test.

    ⅳ) Drug intolerance involves all the serious antiretroviral drug related adverse events, such as AZT related bone marrow suppression, NVP or EFV related serious liver damage and allergic reaction, d4T related lactic acidosis, pancreatitis and peripheral neuritis, etc.

  2. Patients enrolled in the study sign consent form.
  3. Antiretroviral regimen for the subjects:

    The patients enrolled in the study accept a treatment regimen of RAL 400 mg twice daily plus OBT (optimized background therapy), which is selected on the basis of the patient's antiretroviral treatment history, results from all available genotypic resistance tests, previous or current laboratory abnormalities and intolerance to other antiretroviral drugs, and shall, if possible, contain two anti-retroviral drugs fully active against the patient's virus by genotype.

  4. Data collection:

    For each patient, detection of HIV viral load and CD4+ T lymphocyte count is done at screening, and at weeks 4, 12, 24 and 48. The safety profile of RAL is monitored according to patients' complaints and the results of physical and laboratory examinations. Plasma HIV RNA viral loads are determined by HIV-1 Quantiplex(bDNA) assay approved by FDA. CD4+ T lymphocytes are counted with flow cytometry. Any drug-related adverse events that patients experience during treatment will be recorded, such as nausea, vomiting, abdominal pain, abodominal distension, diarrhea, fever, headache, dizzy, fatigue etc. Laboratory examinations cover blood, urine and stool routine, liver and renal function, electrolytes, blood glucose, blood lipid, electrocardiogram etc.

  5. Endpoints of study:

The primary endpoint is the the safety and tolerability of RAL 400 mg b.i.d. in combination with OBT, assessed by review of the accumulated safety data in HIV-infected adult patients. The secondary endpoint is 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 and proportions of patients with: viral load less than 400 copies/ml; viral load less than 50 copies/ml; and a reduction in viral load from baseline exceeding 1.0 log10 copies/ml.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 28, 2014