Human Immunodeficiency Virus Infection Clinical Trial
Official title:
Treatment Perception of QD Dosed Kaletra (Tablets) Based Treatment in HIV Infected Patients. Observational Cross-Sectional Study (QD-KAPITAL)
Both twice-a-day (BID) and once-a-day (QD) dosing are approved in Europe for the protease
inhibitor lopinavir/ritonavir (LPV/r; Kaletra®).
Since once-a-day dosing is actually a driver for human immunodeficiency virus (HIV)-infected
patients to request a specific antiretroviral, the aim of this study is to assess both
patient's perception of and adherence to Kaletra once-a-day, as well as with which factors
they are related.
This is a multicenter, post-marketing, observational, cross-sectional (single visit) study
in HIV-infected patients treated with a combination of antiretroviral treatment (ART)
containing LPV/r 200/50 mg tablets dosed QD for at least 12 weeks to assess the
participants' satisfaction and adherence level with LPV/r QD ART as measured by specific
validated participant questionnaires.
As this is a non-interventional study, the decision to enroll a participant was separate
from the decision to treat the subject with LPV/r. Prescription of LPV/r and duration of
treatment were the responsibility of the treating physician.
In addition, the overall study population was compared to Cohort 2 (394 patients on LPV/r
BID for ≥3 months to <2 years) from KAPITAL2, a post-marketing observational,
cross-sectional, single visit, multicenter, national study. For further details on this
study, please see: Casado JL, Griffa L, Cabrero E, Burgos A, Norton M and the KAPITAL 2
Collaborative Group. A study of treatment satisfaction reported by patients on lopinavir/r
anchored regimens and physicians who provide HIV care (KAPITAL 2). 9th International
Congress on Drug Therapy in HIV Infection. 9th International Congress on Drug Therapy in HIV
Infection. Glasgow, 2008.#P080.
;
Observational Model: Cohort, Time Perspective: Cross-Sectional
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT05981807 -
HPV Infection, Sexually Transmitted Infections and Anal Dysplasia in the Transgender Population
|
||
| Completed |
NCT01490359 -
Men Together Making a Difference: Reducing HIV/STD Risk Behavior Among South African Men
|
N/A | |
| Completed |
NCT03143205 -
Gene Expression Outcomes in Interventions for Substance Using HIV+ Minority Men
|
N/A | |
| Completed |
NCT02738138 -
A Study to Evaluate the Efficacy and Safety of Experimental Drugs ABT- 493/ABT-530 in Adults With Chronic Hepatitis C Virus Genotype 1-6 Infection and Human Immunodeficiency Virus -1 Coinfection (EXPEDITION-2)
|
Phase 3 | |
| Completed |
NCT01791465 -
Pilot Study of Bydureon to Treat Diabetes in HIV-infected Adults
|
Phase 4 | |
| Completed |
NCT01869634 -
Mechanisms of Immune Reconstitution & Reduced Immune Activation Following Darunavir-based ART
|
Phase 4 | |
| Completed |
NCT01662336 -
Real-life Effectiveness of the Kaletra Adherence Support Assistance (KASA) Program
|
N/A | |
| Completed |
NCT01328158 -
Drug Use Investigation of Kaletra Tablets (Once Daily Administration) on Patients With HIV-infection
|
N/A | |
| Completed |
NCT00711009 -
Study Comparing Lopinavir/Ritonavir (LPV/r) + Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) With a Nucleoside Sparing Regimen Consisting of Lopinavir/Ritonavir + Raltegravir (RAL)
|
Phase 3 | |
| Completed |
NCT02817451 -
DTaP-IPV-HB-PRP-T Combined Vaccine as a Primary Series and a Second Year of Life Booster in HIV-Exposed Infected and Uninfected Infants
|
Phase 3 | |
| Completed |
NCT02214173 -
The Effect of an Enhanced Rice Bran Nutritional Supplement in HIV
|
N/A | |
| Completed |
NCT03284645 -
Viral and Antiretroviral Dynamics in HIV-1 Mother-to-Child Transmission Fluids
|
||
| Terminated |
NCT01737359 -
A Safety and Efficacy Study of Amdoxovir in HIV-1 Treatment-experienced Subjects.
|
Phase 2 | |
| Active, not recruiting |
NCT05141422 -
A Drug-drug Interaction Study of SHR2150 on Healthy Chinese Volunteers
|
Phase 1 | |
| Completed |
NCT01939197 -
A Multipart, Open-label Study to Evaluate the Safety and Efficacy of ABT-450/r/ABT-267 With and Without ABT-333 Coadministered With and Without Ribavirin in Adult With Genotype 1 or 4 Hepatitis C Virus (HCV) Infection and Human Immunodeficiency Virus, Type 1 Coinfection
|
Phase 2/Phase 3 | |
| Completed |
NCT01447680 -
Comparison of Plasma & SMARTplasma for Human Immunodeficiency Virus (HIV) and Hepatitis C Virus (HCV) Antibody Testing
|
N/A | |
| Not yet recruiting |
NCT05769413 -
Awareness of Osteoporosis in HIV Patients
|
||
| Withdrawn |
NCT01738555 -
A Safety and Efficacy Study of Amdoxovir in HIV-1 Treatment-experienced Subjects
|
Phase 2 |