Raltegravir-based Antiretroviral Therapy for Resistant HIV-1 Infection
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ClinicalTrials.gov Identifier: NCT01844310 |
Recruitment Status
: Unknown
Verified April 2013 by LI Taisheng, Peking Union Medical College.
Recruitment status was: Not yet recruiting
First Posted
: May 1, 2013
Last Update Posted
: May 1, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
AIDS/HIV PROBLEM | Drug: RAL+TDF+LPV/r Drug: 3TC+TDF+LPV/r | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 300 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Raltegravir-based Antiretroviral Therapy for Resistant HIV-1 Infection in China |
Study Start Date : | May 2013 |
Estimated Primary Completion Date : | December 2015 |
Estimated Study Completion Date : | December 2015 |

Arm | Intervention/treatment |
---|---|
Active Comparator: RAL +TDF+ LPV/r
Arm A: RAL +TDF+ KELETRA(LPV/r) Group A will be assigned with RAL+TDF+LPV/r.
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Drug: RAL+TDF+LPV/r
Group A will be assigned with RAL-based regimen (RAL+TDF+LPV/r).
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Active Comparator: 3TC+ TDF+LPV/r
Arm B: 3TC+ TDF+KELETRA(LPV/r) Group B will be assigned with 3TC+TDF+LPV/r
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Drug: 3TC+TDF+LPV/r
Group B will be assigned with 3TC+TDF+LPV/r
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- Percentage of participants with HIV-1 RNA < 400 copies/mL at week 48 [ Time Frame: 48 weeks ]
- Percentage of participants with HIV-1 RNA < 40 copies/mL at week 48 [ Time Frame: 48 weeks ]
- Change from baseline in CD4 count at week 48 [ Time Frame: Baseline and 48 weeks ]
- Incidence of adverse events and laboratory abnormalities in the two treatment arms from baseline to week 48 [ Time Frame: through week 48 ]

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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:
- Age between 18-65 years
- HIV seropositive and confirmed by western blot
-
have taken first line antiretroviral therapy for over one year and have any one of the criteria listed below (viral load of all the patients meeting these criteria should be confirmed at PUMCH laboratory)
- Viral load more than 400 copies/ml
- Viral rebound (confirmed by HIV RNA more than 400 copies/ml after virologic suppression)
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When viral load cannot be monitored, patients experience immunologic failure who meet at least one of the criteria listed below will be enrolled:
- CD4 count equal to or lower than baseline level with first-line therapy,on two occasions over three months apart
- CD4 count with 50 percentage fall from the on-treatment peak value
- persistent CD4 count levels less than 100 cells/μl after over one-year antiretroviral therapy
Exclusion Criteria:
- Previous use of protease inhibitors
- Previous use of integrase inhibitors
- Pregnancy and breastfeeding
- poor compliance and drug interaction,
- opportunistic infections or malignancy at recruitment; or opportunistic infections within three months but still unstable within 14 days prior to recruitment
- HBsAg positive
- patients with the any of the following test results during screening for inclusion: WBC count<2000/μl, neutrophil count<1000/μl, Hb<9g/dl, platelet count<75000/μl, serum creatinine>1.5 ULN, transaminases or alkaline phosphatase >3 ULN, total bilirubin>2 ULN, serum creatinine kinase>2 ULN
- CCr<60 ml/min
- Current intravenous drug use
- Severe neuropathy or mental disorder
- history of alcohol abuse and unable to withdrawal
- Severe peptic ulcer

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): NCT01844310
Contact: Taisheng Li, MD | 86-10-69155086 | litsh@263.net |
China | |
Peking Union Medical College Hospital | Not yet recruiting |
Beijing, China, 100730 | |
Contact: Wei Lv, MD 86-10-69155082 lvweipumch@163.com | |
Principal Investigator: Taisheng Li, MD |
Responsible Party: | LI Taisheng, director of the Department of Infectious Disease, Peking Union Medical College |
ClinicalTrials.gov Identifier: | NCT01844310 History of Changes |
Other Study ID Numbers: |
CACT1215-01 |
First Posted: | May 1, 2013 Key Record Dates |
Last Update Posted: | May 1, 2013 |
Last Verified: | April 2013 |
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 |