Raltegravir-based Antiretroviral Therapy for Resistant HIV-1 Infection

This study is not yet open for participant recruitment.
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
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Raltegravir-based Antiretroviral Therapy for Resistant HIV-1 Infection in China

Resource links provided by NLM:


Further study details as provided by Peking Union Medical College:

Primary Outcome Measures:
  • Percentage of participants with HIV-1 RNA < 400 copies/mL at week 48 [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 300
Study Start Date: May 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: August 25, 2012
Last Updated: April 26, 2013
Health Authority: China: Ministry of Science and Technology

Additional relevant MeSH terms:
Lamivudine
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on April 16, 2014