NCT00627055

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_4 hiv-infections

Timeline
Completed

Started May 2008

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 21, 2008

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 29, 2008

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2008

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

July 17, 2020

Status Verified

July 1, 2020

Enrollment Period

2.5 years

First QC Date

February 21, 2008

Last Update Submit

July 15, 2020

Conditions

HIV Infections

Keywords

Second line antiretroviral therapyHIV genotypic resistanceKaletra monotherapyThailand48-week efficacy and safety between 2 NRTIs plus lopinavir/ritonavir (LPV/r) and LPV/r monotherapy in patients failing a standard NNRTI-based treatment regimentreatment experienced

Outcome Measures

Primary Outcomes (1)

  • To evaluate the 48-week efficacy and safety between 2 NRTIs plus lopinavir/ritonavir (LPV/r) and LPV/r monotherapy in patients failing a standard NNRTI-based treatment regimen

    48 weeks

Secondary Outcomes (1)

  • To evaluate the short-term 24-week efficacy and safety of LPV/r monotherapy and interim analyses when 50% of the patients in each arm have reached 24 weeks after randomization 2. To define risk factors for monotherapy failure in HIV-treated individuals

    48 weeks

Study Arms (2)

1

EXPERIMENTAL

LPV/r monotherapy

Drug: LPV/r

2

ACTIVE COMPARATOR

LPV/r + 2NRTIs (TDF/FTC or TDF/3TC)

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

Interventions

LPV/rDRUG

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

1
LPV/r + TDF/FTC or TDF/3TCDRUG

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

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years.
  • HIV seropositive.
  • Have had NNRTI-based HAART in the past for at least 6 months
  • Naïve to protease inhibitors (PIs)
  • Plasma HIVRNA ≥ 1000 copies/ml
  • Signed written informed consent

You may not qualify if:

  • Active AIDS-defining disease or active opportunistic infection
  • Previously treated with PIs
  • Pregnancy (negative pregnancy test for women of childbearing potential at screening).
  • Documented chronic hepatitis B (HbsAg positive)
  • ALT ≥ 200 U/L
  • Creatinine clearance \< 60 c.c. per min by Cockroft-Gault formula formula
  • Use of medication that interfere with the action of LPV/r

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Chonburi Hospital

Chon Buri, Changwat Chon Buri, Thailand

Location

Chulalongkorn University

Bangkok, 10330, Thailand

Location

Hivnat, Trcarc

Bangkok, 10330, Thailand

Location

Siriraj Hospital

Bangkok, 10700, Thailand

Location

Ramathibodi Hospital

Bangkok, Thailand

Location

Taksin Hospital

Bangkok, Thailand

Location

Sanpatong Hospital

Chiang Mai, Thailand

Location

Chiang Rai Regional Hospital

Chiang Rai, Thailand

Location

Khon Kaen University

Khon Kaen, 40002, Thailand

Location

Bamrasnaradura Institute

Nonthaburi, 11000, Thailand

Location

Related Publications (4)

  • Parsons MS, Madhavi V, Ana-Sosa-Batiz F, Center RJ, Wilson KM, Bunupuradah T, Ruxrungtham K, Kent SJ. Brief Report: Seminal Plasma Anti-HIV Antibodies Trigger Antibody-dependent Cellular Cytotoxicity: Implications for HIV Transmission. J Acquir Immune Defic Syndr. 2016 Jan 1;71(1):17-23. doi: 10.1097/QAI.0000000000000804.

    PMID: 26761269DERIVED

  • Bunupuradah T, Chetchotisakd P, Ananworanich J, Munsakul W, Jirajariyavej S, Kantipong P, Prasithsirikul W, Sungkanuparph S, Bowonwatanuwong C, Klinbuayaem V, Kerr SJ, Sophonphan J, Bhakeecheep S, Hirschel B, Ruxrungtham K; HIV STAR Study Group. A randomized comparison of second-line lopinavir/ritonavir monotherapy versus tenofovir/lamivudine/lopinavir/ritonavir in patients failing NNRTI regimens: the HIV STAR study. Antivir Ther. 2012;17(7):1351-61. doi: 10.3851/IMP2443. Epub 2012 Jul 2.

    PMID: 23075703DERIVED

  • Bunupuradah T, Chetchotisakd P, Jirajariyavej S, Valcour V, Bowonwattanuwong C, Munsakul W, Klinbuayaem V, Prasithsirikul W, Sophonphan J, Mahanontharit A, Hirschel B, Bhakeecheep S, Ruxrungtham K, Ananworanich J; HIV STAR Study Group. Neurocognitive impairment in patients randomized to second-line lopinavir/ritonavir-based antiretroviral therapy vs. lopinavir/ritonavir monotherapy. J Neurovirol. 2012 Dec;18(6):479-87. doi: 10.1007/s13365-012-0127-9. Epub 2012 Sep 20.

    PMID: 22993101DERIVED

  • Bunupuradah T, Ananworanich J, Chetchotisakd P, Kantipong P, Jirajariyavej S, Sirivichayakul S, Munsakul W, Prasithsirikul W, Sungkanuparph S, Bowonwattanuwong C, Klinbuayaem V, Petoumenos K, Hirschel B, Bhakeecheep S, Ruxrungtham K. Etravirine and rilpivirine resistance in HIV-1 subtype CRF01_AE-infected adults failing non-nucleoside reverse transcriptase inhibitor-based regimens. Antivir Ther. 2011;16(7):1113-21. doi: 10.3851/IMP1906.

    PMID: 22024527DERIVED

Related Links

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Kiat Ruxrungtham, MD

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

    PRINCIPAL INVESTIGATOR

  • Bernard Hirschel, MD

    Geneva University, Geneva, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2008

First Posted

February 29, 2008

Study Start

May 1, 2008

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

July 17, 2020

Record last verified: 2020-07

Locations

TH(10)