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NCT01139905
Pharmacokinetics of Low- Dose Lopinavir/Ritonavir Tablet Formulation HIV-1 Infected Children
Phase 2 trial testing lopinavir/ritonavir in HIV-1 Infections in 24 participants. Completed in 1 March 2011.
1 March 2011
Quick facts
| Lead sponsor | The HIV Netherlands Australia Thailand Research Collaboration |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Enrollment | 24 |
| Start date | 1 April 2010 |
| Primary completion | 1 March 2011 |
| Estimated completion | 1 March 2011 |
| Sites | 1 location across Thailand |
Drugs / interventions tested
- lopinavir/ritonavir
Conditions studied
- HIV-1 Infections — all drugs for HIV-1 Infections →
Sponsor
The HIV Netherlands Australia Thailand Research Collaboration — full company profile →
Who can join
Adults 1 to 18, any sex, with HIV-1 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.
-
assess the level of lopinavir trough level >1 mg/L in low dose lopinavir (reduction by 70%)
Time frame: 4 months
study drug Aluvia (lopinavir/ritonavir 100/25 mg)
Sponsor's own description
To study the pharmacokinetics of low-dose lopinavir/ritonavir tablet in HIV-1 infected Thai children.
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:
- PubMed search for NCT01139905
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of lopinavir/ritonavir
Trials testing the same drug.
- NCT02581202 — The Effectiveness of Dual Therapy (Lopinavir/Ritonavir + LamivudinE) in Treatment-Experienced HIV Infected Patients in t · completed
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)
- Trial protocol + status: ClinicalTrials.gov NCT01139905 (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: 24 March 2015
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/NCT01139905.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing