HIV-1 Clinical Trial
Official title:
A Phase II, Open-label Trial, to Evaluate the Safety, Tolerability and Antiviral Activity of TMC125 in Antiretroviral Experienced HIV-1 Infected Children and Adolescents
The purpose of this study is to determine the safety and antiviral activity of etravirine in treatment-experienced human immunodeficiency virus (HIV) infected children and adolescents.
The study design is a single arm treatment (all patients assigned to receive etravirine), open label (patients will know the identity of the treatments they are receiving) safety and antiviral activity of Etravirine (TMC125) in treatment-experienced, HIV infected children and adolescents 6 to 17 years of age. Etravirine is a new drug belonging to the NNRTI (a non-nucleoside reverse transcriptase inhibitor) drug class that slows down the growth of the human immunodeficiency virus (HIV). This drug has been tested for safety and effectiveness in adults, however, there is no data on the drug's long-term safety and antiviral activity in children and adolescents. This study will last for a maximum of 48 weeks. A total of 100 ptients will receive etravirine tablets based on body weight and an investigator selected optimized background regimen (OBR) of at least 2 antiretrovirals (ARVs), consisting of a boosted protease inhibitor (PI) and nucleoside reverse transcriptase inhibitor(s) (NRTI[s]). Use of enfuvirtide is optional. Safety will be monitored throughout the study. ;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01968551 -
Phase 3 Open-Label Study to Evaluate Switching From Optimized Stable Antiretroviral Regimens Containing Darunavir to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Fixed Dose Combination (FDC) Plus Darunavir (DRV) in Treatment Experienced HIV-1 Positive Adults
|
Phase 3 | |
| Terminated |
NCT03708289 -
Body Composition, Bone Health and Hormonal Status in HIV-1-infected Individuals
|
||
| Completed |
NCT02547844 -
Evolution of Plasma Lipid Profile in Patients With HIV1 Who Change Atripla to Eviplera Compared to Continue With Atripla
|
Phase 4 | |
| Terminated |
NCT01345630 -
Comparative Trial Of Maraviroc Versus Emtricitabine/Tenofovir Both With Darunavir/Ritonavir In Antiretroviral-Naive Patients Infected With CCR5 Tropic HIV 1
|
Phase 3 | |
| Terminated |
NCT01173276 -
Intrauterine Insemination In HIV-Discordant Couples
|
N/A | |
| Completed |
NCT00807443 -
Effect Of An Integrase Inhibitor On The Latency And Reservoir Of HIV-1
|
Phase 2 | |
| Completed |
NCT01140139 -
Dermal HIV-1 Immunization During Anti-retroviral Therapy Followed by Repeated Treatment Interruptions
|
Phase 1 | |
| Withdrawn |
NCT00340223 -
HLA-B35 Alleles and AIDS
|
N/A | |
| Completed |
NCT00097006 -
Retrovirus Epidemiology Donor Study-II (REDS-II)
|
N/A | |
| Completed |
NCT02217904 -
A Study of Islatravir (MK-8591) in Anti-Retroviral Therapy-Naive, Human Immunodeficiency Virus-1 Infected Participants (MK-8591-003)
|
Phase 1 | |
| Completed |
NCT00772902 -
ROCKET II - Randomized Open Label Switch for Cholesterol Elevation on Kivexa + Kaletra Evaluation Trial
|
Phase 4 | |
| Completed |
NCT04006704 -
Study to Assess the Acceptability of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Fixed-Dose Combination (FDC) Tablets in Human Immunodeficiency Virus Type 1 (HIV-1) Infected Pediatric Participants, Using Matching Placebo Tablets
|
Phase 1 | |
| Terminated |
NCT03060629 -
A Study to Assess the Efficacy of a Heterologous Prime/Boost Vaccine Regimen of Ad26.Mos4.HIV and Aluminum Phosphate-Adjuvanted Clade C gp140 in Preventing Human Immunodeficiency Virus (HIV) -1 Infection in Women in Sub-Saharan Africa
|
Phase 2 | |
| Recruiting |
NCT00981695 -
Safety and Immunogenicity Study of Candidate HIV-1 Vaccine Given to Healthy Infants Born to HIV-1-infected Mothers
|
Phase 1/Phase 2 | |
| Completed |
NCT01084343 -
Investigation of the Safety of an HIV-1 Vaccine Given Intra-muscularly and Intra-nasally to Healthy Female Subjects
|
Phase 1 | |
| Completed |
NCT00982579 -
Safety and Immunogenicity Study of Candidate HIV-1 Vaccine Given to Healthy Infants Born to HIV-1/2-uninfected Mothers
|
Phase 1 | |
| Completed |
NCT00098293 -
Trial of Maraviroc (UK-427,857) in Combination With Zidovudine/Lamivudine Versus Efavirenz in Combination With Zidovudine/Lamivudine
|
Phase 3 | |
| Completed |
NCT05944848 -
A Study of CL-197 Capsules in Healthy Participants
|
Phase 1 | |
| Completed |
NCT00479999 -
Phase 1 Safety Study of Two Experimental HIV Vaccines
|
Phase 1 | |
| Completed |
NCT01274780 -
Metabolic Effects of Atazanavir/Ritonavir Versus Darunavir/Ritonavir in Combination With Tenofovir/Emtricitabine in naïve HIV-1 Infected Patients
|
Phase 4 |