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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
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This study is to evaluate the safety and efficacy of RAL-based regimen in treatment-experienced patients with resistant HIV infection

Condition or disease Intervention/treatment
AIDS/HIV PROBLEM Drug: RAL+TDF+LPV/r Drug: 3TC+TDF+LPV/r

Detailed Description:
In our study, both efficacy and safety of raltegravir(RAL)-based therapy will be assessed. 300 treatment-experienced patients with drug-resistant HIV will be randomized to two arms (2:1). Group A (n=200) will be assigned with RAL-based regimen (RAL+TDF+LPV/r).Group B (n=100) will be assigned with current second-line regimen in China (3TC+TDF+LPV/r). Both virological and immunological profiles and responses at baseline and at week 4, 8, 12, 24, 36, and 48 will be evaluated. This study will be the first large-scale, multicenter, randomized, prospective RAL-based therapy study in China for HIV/AIDs patients. The result will provide proves for further practical antiviral therapy for China or other resource-limiting countries.

Study Design

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

Resource links provided by the National Library of Medicine

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

Arms and Interventions

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.
Drug: RAL+TDF+LPV/r
Group A will be assigned with RAL-based regimen (RAL+TDF+LPV/r).
Active Comparator: 3TC+ TDF+LPV/r
Arm B: 3TC+ TDF+KELETRA(LPV/r) Group B will be assigned with 3TC+TDF+LPV/r
Drug: 3TC+TDF+LPV/r
Group B will be assigned with 3TC+TDF+LPV/r


Outcome Measures

Primary Outcome Measures :
  1. Percentage of participants with HIV-1 RNA < 400 copies/mL at week 48 [ Time Frame: 48 weeks ]

Secondary Outcome Measures :
  1. Percentage of participants with HIV-1 RNA < 40 copies/mL at week 48 [ Time Frame: 48 weeks ]
  2. Change from baseline in CD4 count at week 48 [ Time Frame: Baseline and 48 weeks ]
  3. Incidence of adverse events and laboratory abnormalities in the two treatment arms from baseline to week 48 [ Time Frame: through week 48 ]

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:

  1. Age between 18-65 years
  2. HIV seropositive and confirmed by western blot
  3. 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)

    1. Viral load more than 400 copies/ml
    2. Viral rebound (confirmed by HIV RNA more than 400 copies/ml after virologic suppression)
    3. 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
Contacts and Locations

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): NCT01844310


Contacts
Contact: Taisheng Li, MD 86-10-69155086 litsh@263.net

Locations
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         
Sponsors and Collaborators
Peking Union Medical College
More Information

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