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
Recruitment status was Not yet recruiting
Sponsor:
Shanghai Public Health Clinical Center
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
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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
|
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
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
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 March 03, 2015