Raltegravir-based Antiretroviral Therapy for Resistant HIV-1 Infection

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2013 by Peking Union Medical College
Sponsor:
Information provided by (Responsible Party):
LI Taisheng, Peking Union Medical College
ClinicalTrials.gov Identifier:
NCT01844310
First received: August 25, 2012
Last updated: April 26, 2013
Last verified: April 2013

August 25, 2012
April 26, 2013
May 2013
December 2015   (final data collection date for primary outcome measure)
Percentage of participants with HIV-1 RNA < 400 copies/mL at week 48 [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01844310 on ClinicalTrials.gov Archive Site
  • Percentage of participants with HIV-1 RNA < 40 copies/mL at week 48 [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in CD4 count at week 48 [ Time Frame: Baseline and 48 weeks ] [ Designated as safety issue: No ]
  • Incidence of adverse events and laboratory abnormalities in the two treatment arms from baseline to week 48 [ Time Frame: through week 48 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Raltegravir-based Antiretroviral Therapy for Resistant HIV-1 Infection
Raltegravir-based Antiretroviral Therapy for Resistant HIV-1 Infection in China

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

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
AIDS/HIV PROBLEM
  • Drug: RAL+TDF+LPV/r
    Group A will be assigned with RAL-based regimen (RAL+TDF+LPV/r).
  • Drug: 3TC+TDF+LPV/r
    Group B will be assigned with 3TC+TDF+LPV/r
  • Active Comparator: RAL +TDF+ LPV/r
    Arm A: RAL +TDF+ KELETRA(LPV/r) Group A will be assigned with RAL+TDF+LPV/r.
    Intervention: Drug: 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
    Intervention: Drug: 3TC+TDF+LPV/r
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
300
December 2015
December 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact: Taisheng Li, MD 86-10-69155086 litsh@263.net
China
 
NCT01844310
CACT1215-01
Yes
LI Taisheng, Peking Union Medical College
Peking Union Medical College
Not Provided
Not Provided
Peking Union Medical College
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP