Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| TMC114HIV4073 | Other Identifier | Janssen-Cilag Ltd. | |
| DRV-C-10-TW01-001 | Other Identifier | Janssen-Cilag Ltd. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to provide early access to TMC114 administered with low-dose ritonavir (TMC114/r) and other antiretrovirals (ARVs) for HIV-1-infected patients who have not received previous HIV treatment or have received early treatment without TMC114 regimens.
This is a single-treatment-group, open-label (patients and study personnel will know the identity of the treatments given), single-center study. The primary goal of this study is to provide early access to TMC114 administered with low-dose ritonavir (TMC114/r) and other antiretrovirals (ARVs, agents that are used to treat viral infections). This study is intended for HIV-1-infected patients who have not received previous HIV treatment (treatment-naive patients) or have received early treatment without TMC114 regimens and who are ineligible to participate in any other sponsored HIV-1 study. This study will monitor and evaluate the safety and efficacy of TMC114/r in combination with ARVs during the course of the study. Treatment with TMC114/r will be continued until virologic failure (the inability to achieve or maintain suppression of viral replication), treatment-limiting toxicity, loss to follow-up, study withdrawal, pregnancy, until discontinuation of TMC114 development or when TMC114 becomes reimbursable for treatment-naive patients or when TMC114 becomes commercially available for treatment-experienced patients.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TMC114/ritonavir | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TMC114/ritonavir | Drug | TMC114 800 mg (two tablets) once daily coadministered with ritonavir 100 mg (one capsule) once daily within 30 minutes after completion of a meal, and in combination with other ARVs. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in plasma HIV-1 RNA level | End-of-study visit is defined as the time TMC114 becomes commercially available or reimbursed for treatment-naïve patients. | Day 1 (Baseline) up to end-of-study visit, an expected average of approximately 3 months |
| Change in plasma CD4 cell count | End-of-study visit is defined as the time TMC114 becomes commercially available or reimbursed for treatment-naïve patients. | Day 1 (Baseline) up to end-of-study visit, an expected average of approximately 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants affected by an adverse event | End-of-study visit is defined as the time TMC114 becomes commercially available or reimbursed for treatment-naïve patients. | Up to end-of-study visit, an expected average of approximately 3 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Chien-Ching Hung, MD and PhD | National Taiwan University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taipei | Taiwan |
Not provided
| Label | URL |
|---|---|
| Early access to TMC114 in combination with low-dose ritonavir (tmc114/r) and other Antiretrovirals (AVRs) for treatment-naïve or TMC114-naïve, early treatment-experienced in HIV-1 infected patients. | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069454 | Darunavir |
| D019438 | Ritonavir |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D002219 | Carbamates |
| D000144 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D005663 | Furans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013844 | Thiazoles |
| D001393 | Azoles |