Who is sponsoring NCT01116817?

NCT01116817 is sponsored by Germans Trias i Pujol Hospital.

What drugs are being tested in NCT01116817?

Interventions in NCT01116817: Lumbar puncture (Lopinavir/ritonavir monotherapy), Lumbar puncture (HAART: Lopinavir/ritonavir + 2 NRTI).

Is NCT01116817 still recruiting?

NCT01116817 is currently completed. Last updated 3 December 2019.

Last reviewed 2019-12-03 · How we verify

NCT01116817

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

Exploratory, Cross-sectional Study to Compare the Virologic Efficacy in Cerebrospinal Fluid (CSF) and Neurocognitive State in Patients Infected by HIV-1 Long-term Treatment (> 3 Years) With Lopinavir / Ritonavir Monotherapy

Completed Phase 4 Last updated 3 December 2019

What this trial tests

Phase 4 trial testing Lumbar puncture (Lopinavir/ritonavir monotherapy) in HIV in 35 participants. Completed in 1 June 2011.

Timeline

1 August 2010

Primary endpoint
1 June 2011

1 June 2011

Quick facts

Lead sponsor	Germans Trias i Pujol Hospital
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	35
Start date	1 August 2010
Primary completion	1 June 2011
Estimated completion	1 June 2011
Sites	1 location across Spain

Drugs / interventions tested

Lumbar puncture (Lopinavir/ritonavir monotherapy) — full drug profile →
Lumbar puncture (HAART: Lopinavir/ritonavir + 2 NRTI) — full drug profile →

Conditions studied

HIV — all drugs for HIV →

Sponsor

Germans Trias i Pujol Hospital

Who can join

Adults 18 to 65, any sex, with HIV. 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.

Ultrasensitive HIV-1 RNA in CSF
Time frame: week 0

Sponsor's own description

The aim of this study is to describe and compare the percentage of patients infected by HIV-1 to maintain a complete virology suppression at the CSF (CSF CV 1 copy / mL) in patients with CV \<50 copies / mL and treated with stable antiretroviral therapy for at least 3 years with LPV / r 400/100 mg twice daily + 2 NRTI.

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:

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Other Germans Trias i Pujol Hospital trials

Trials by the same sponsor.

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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 NCT01116817 (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 Germans Trias i Pujol Hospital
Last refreshed: 3 December 2019

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/NCT01116817.

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