NCT00627055 is a Phase 4 clinical trial of LPV/r in HIV Infections, sponsored by The HIV Netherlands Australia Thailand Research Collaboration.

Who is sponsoring NCT00627055?

NCT00627055 is sponsored by The HIV Netherlands Australia Thailand Research Collaboration.

What drugs are being tested in NCT00627055?

Interventions in NCT00627055: LPV/r, LPV/r + TDF/FTC or TDF/3TC.

What condition does NCT00627055 study?

NCT00627055 studies HIV Infections.

Is NCT00627055 still recruiting?

NCT00627055 is currently completed. Last updated 15 July 2020.

Last reviewed 2020-07-15 · How we verify

NCT00627055

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

The HIV Second-line Therapy AntiRetroviral Study in Patients Who Failed NNRTI-based Regimens

Completed Phase 4 Last updated 15 July 2020

What this trial tests

Phase 4 trial testing LPV/r in HIV Infections in 200 participants. Completed in 1 November 2010.

Timeline

1 May 2008

Primary endpoint
1 November 2010

1 November 2010

Quick facts

Lead sponsor	The HIV Netherlands Australia Thailand Research Collaboration
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	200
Start date	1 May 2008
Primary completion	1 November 2010
Estimated completion	1 November 2010
Sites	10 locations across Thailand

Drugs / interventions tested

LPV/r — full drug profile →
LPV/r + TDF/FTC or TDF/3TC — full drug profile →

Conditions studied

HIV Infections — all drugs for HIV Infections →

Sponsor

The HIV Netherlands Australia Thailand Research Collaboration — full company profile →

Who can join

18 and older, any sex, with HIV Infections. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

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
Time frame: 48 weeks

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for HIV Infections

Currently open trials in the same condition.

NCT07225530 — Implementation of Screen, Treat, and Triage for Women Living With HIV in La Romana (iSTAR) · NA · recruiting
NCT07202546 — A Phase 2b Study Evaluating Oral VH4524184 Regimens in Treatment Naïve Persons With HIV-1 (INNOVATE Study) · Phase 2 · recruiting
NCT06694753 — Safety and Immunogenicity Study of Three mRNAs Encoding HIV Immunogens in Adult Participants Without HIV and in Overall · Phase 1 · recruiting
NCT07235852 — Pilot Testing Into the Feasibility of the Developed Cognitive Behavioral Therapy Intervention · NA · recruiting
NCT06665646 — Clinical Trial to Evaluate the Safety and Immunogenicity of Hiltonol, Poly-ICLC-adjuvanted CD40.HIVRI.Env (VRIPRO) in Ad · Phase 1 · recruiting

Other The HIV Netherlands Australia Thailand Research Collaboration trials

Trials by the same sponsor.

NCT04552015 — Microneedles for Diagnosis of LTBI · NA · terminated
NCT03731559 — Efficacy, Safety and Pharmacokinetics of DTG with RIF · Phase 2 · recruiting
NCT03835832 — Self-Assessment Tuberculin Skin Test · completed
NCT03727152 — Switching From Protease Inhibitor/Ritonavir to Generic Single Tablet Regimen of Tenofovir Alafenamide/Emtricitibine/Dolu · Phase 3 · completed
NCT03037151 — Safety and Efficacy of Grazoprevir and Elbasvir for GT1ang GT6 With and Without HIV · Phase 4 · unknown

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00627055 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by The HIV Netherlands Australia Thailand Research Collaboration
Last refreshed: 15 July 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00627055.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing