Raltegravir-based Antiretroviral Therapy for Resistant HIV-1 Infection

AIDS/HIV PROBLEM Clinical Trial

Official title:

Raltegravir-based Antiretroviral Therapy for Resistant HIV-1 Infection in China

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01844310
• Other study ID #: CACT1215-01
• Status: Not yet recruiting
• Phase: N/A
• First received: August 25, 2012
• Last updated: April 26, 2013
• Start date: May 2013
• Est. completion date: December 2015

Study information

• Verified date: April 2013
• Source: Peking Union Medical College
• Contact: Taisheng Li, MD
• Phone: 86-10-69155086
• Email: litsh[@]263.net
• Is FDA regulated: No
• Health authority: China: Ministry of Science and Technology
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• AIDS/HIV PROBLEM

Intervention

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

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants with HIV-1 RNA < 400 copies/mL at week 48		48 weeks	No
Secondary	Percentage of participants with HIV-1 RNA < 40 copies/mL at week 48		48 weeks	No
Secondary	Change from baseline in CD4 count at week 48		Baseline and 48 weeks	No
Secondary	Incidence of adverse events and laboratory abnormalities in the two treatment arms from baseline to week 48		through week 48	Yes