Maintenance Boosted Lopinavir Monotherapy Following Salvage Protease-inhibitor (PI) Based Regimen in HIV With Non-nucleoside Reverse Transcriptase Inhibitors (NNRTI) Based Regimen Failure

HIV Clinical Trial

— BIDI-MONO  

Official title:

A Randomized Controlled Study Compares the 48 Weeks Results of HIV-1 RNA Between Ritonavir-boosted Lopinavir Monotherapy and Ritonavir-boosted Lopinavir + Optimized Background Regimens in HIV-1 Infected Patients Who Have HIV-1 RNA <50 Copies/ml More Than 6 Months While Receiving Salvage PI-based Regimen and Previously Failed NNRTI-based Regimen

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01189695
• Other study ID #: BIDI-MONO
• Status: Completed
• Phase: Phase 4
• First received: August 26, 2010
• Last updated: May 10, 2013
• Start date: December 2010
• Est. completion date: January 2013

Study information

• Verified date: May 2013
• Source: Bamrasnaradura Infectious Diseases Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ministry of Public Health
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to determine efficacy of ritonavir-boosted lopinavir monotherapy as a maintenance regimen in HIV-1-infected patients who previously failed Non-nucleoside reverse transcriptase inhibitors (NNRTI) based regimens and currently received salvage protease-inhibitor (PI) based regimens.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: January 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• age 18-60 years

• documented HIV infection

• previously failed to NNRTI-based regimens

• no history of failing PI-based regimens

• receiving ritonavir-boosted PI + OBRs(such as NRITs, etravirine, raltegravir)

• having HIV-1 RNA <50 copies/ml for at least prior 6 months

Exclusion Criteria:

• Pregnant or breastfeeding woman

• HBV co-infection that had to treated with TDF, FTC or 3TC

• had to received medications known to have potential significant drug interaction with LPV/r

• life expectancy less than 6 months

• serious systemic diseases such as liver cirrhosis Child-Pugh B/C, ESRD, malignancy

• hemoglobin <8 g/dl, platelet <50,000/mm3, AST or ALT >3 ULN, estimated creatinine clearance <50 mL/min

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
• Lopinavir
• Treatment Failure

Intervention

Drug:
• Ritonavir-boosted lopinavir
Lopinavir/ritonavir 200/50 mg every 12 hours
• optimized background regimens (OBRs)
Optimized background regimens such as NRTIs, etravirine or raltegravir

Locations

Country	Name	City	State
Thailand	Bamrasnaradura Infectious Diseases Institute	Nonthaburi

Sponsors (2)

Lead Sponsor	Collaborator
Bamrasnaradura Infectious Diseases Institute	Department of Disease Control, Thailand

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to virological failure	virological failure was defined as having two consecutive results of HIV-1 RNA >400 copies/ml in time separated by 4 weeks	48 weeks	Yes
Secondary	Proportion of patients with virological suppression	virological suppression defined as having HIV-1 RNA <40 copies/ml	48 weeks	Yes
Secondary	Proportion of patients with virological failure	virological failure was defined as having two consecutive results of HIV-1 RNA >400 copies/ml in time separated by 4 weeks	48 week	Yes
Secondary	Time to loss of virological response (TLOVR)	TLOVR was defined as time between randomization and the last value that HIV-1 RNA <40 copies/ml in a patient who initially suppressed HIV-1 RNA but subsequently demonstrated virologic rebound (two consecutive HIV-1 RNA >40 copies/ml)	48 weeks	Yes
Secondary	Change of CD4 cells count	Change of CD4 cells count from start of study to Week 48	48 weeks	No
Secondary	Adverse events	any grade 3 or grade 4 adverse events according to DAIDS AE grading table	48 weeks	Yes