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Second-line Therapy Antiretroviral in Patients Who Failed Non-nucleoside Reverse Transcriptase Inhibitor (NNRTI) - Based Regimens

NCT00627055 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2020-07-17

No results posted yet for this study

Summary

To evaluate the efficacy and safety at 48 weeks between LPV/r monotherapy and 2 NRTIs + LPV/r therapy in patients failing a standard NNRTI-based treatment regimen. Also, to evaluate the short-term 24-week efficacy and safety of Lopinavir/ritonavir (LPV/r) monotherapy and 2 NRTIs+LPV/r therapy in patients failing a standard NNRTI-based treatment regimen as an interim analyses when 50% of the patients in each arm have reached 24 weeks after randomization. Last, to define risk factors for monotherapy failure in HIV-treated individuals

Hypothesis. The rate of virologic suppression is not inferior in the monotherapy arm.

Conditions

  • HIV Infections

Interventions

DRUG

LPV/r

LPV/r dosing = 400mg/100mg orally q12h for 48 weeks

DRUG

LPV/r + TDF/FTC or TDF/3TC

TDF/FTC (Truvada) 1 pill orally q 24 hr or TDF 300mg orally q 24 hr/3TC 300mg orally q 24 hr (or 3TC 150mg orally q 12 hr) for 48 weeks

Sponsors & Collaborators

  • National Health Security Office, Thailand

    collaborator OTHER

  • Swiss HIV Cohort Study

    collaborator NETWORK

  • The HIV Netherlands Australia Thailand Research Collaboration

    lead OTHER

Principal Investigators

  • Kiat Ruxrungtham, MD · HIV-NAT, The Thai Red Cross AIDS Research Centre (TRCARC), and Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand

  • Bernard Hirschel, MD · Geneva University, Geneva, Switzerland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2010-11-30
Completion
2010-11-30

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00627055 on ClinicalTrials.gov