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

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 |

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.
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Drug: raltegravir
RAL 400 mg twice daily plus OBT (optimized background therapy) for 48 weeks
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- 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 ]
- 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 ]

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Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
China, Shanghai | |
Shanghai Public Health Clinical Center | Not yet recruiting |
Shanghai, Shanghai, China, 201508 |
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 |