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Completed

NCT Number: NCT01189695

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

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.

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Key information

Conditions

HIV AIDS Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Lopinavir RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Treatment Failure Urogenital Diseases Virus Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Bamrasnaradura Infectious Diseases Institute

Nonthaburi, 11000, Thailand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ritonavir-boosted lopinavir

Drug

Lopinavir/ritonavir 200/50 mg every 12 hours

optimized background regimens (OBRs)

Drug

Optimized background regimens such as NRTIs, etravirine or raltegravir

Primary outcomes

  1. Time to virological failure

    Time frame: 48 weeks

    virological failure was defined as having two consecutive results of HIV-1 RNA >400 copies/ml in time separated by 4 weeks

Secondary outcomes

  1. Proportion of patients with virological suppression

    Time frame: 48 weeks

    virological suppression defined as having HIV-1 RNA <40 copies/ml

  2. Proportion of patients with virological failure

    Time frame: 48 week

    virological failure was defined as having two consecutive results of HIV-1 RNA >400 copies/ml in time separated by 4 weeks

  3. Time to loss of virological response (TLOVR)

    Time frame: 48 weeks

    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)

  4. Change of CD4 cells count

    Time frame: 48 weeks

    Change of CD4 cells count from start of study to Week 48

  5. Adverse events

    Time frame: 48 weeks

    any grade 3 or grade 4 adverse events according to DAIDS AE grading table

Sponsors and collaborators

Lead sponsor

Bamrasnaradura Infectious Diseases Institute

Other Gov

Collaborators

  • Department of Disease Control, Thailand

Registry information

Official study 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

Acronym: BIDI-MONO

Important dates

Study start
2010
Primary completion
2012
Study completion
2013
First posted
Aug 27, 2010
Registry last updated
May 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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