Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2009-016090-14 | Other Identifier | EudraCT Number |
Not provided
Not provided
patient sample not reached
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 objective is to analyse the changes in the adipose tissue hystological features and the adipogenesis gene expression and related to inflammation after 48 and 96 weeks after the change from AZT+3TC+ABC (Trizivir®) to a monotherapy treatment with LPV/r (Kaletra®)
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Kaletra, all patients | Experimental | Patients will change actual treament for monotherapy LPV/r. They only will take Kaletra 2/day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Kaletra | Drug | Each tablet of Kaletra contains 200 mg of Lopinavir and 50mg of ritonavir. The patients will take two tablets of Kaletra bid. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in those representative gene expression of adipose tissue toxicity (variable established from those gene involved in adipogenesis, inflammation and metabolism. This gene expression will counted) | 48 and 96 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in physical fat deposits | Baseline, 24, 48, 72 and 96 weeks | |
| Changes in leptine and adiponectine plasma levels | baseline, 24, 48, 72 and 96 weeks | |
| Patients percentage with virologic response (ARN-VIH< 50 copies/mL) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Vicente Estrada, MD | hospital ClÃnico San Carlos, Madrid | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fundación Jiménez DÃaz | Madrid | Madrid | 28040 | Spain | ||
| Hospital ClÃnico San Carlos |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 48 and 96 weeks |
| Madrid |
| Madrid |
| 28040 |
| Spain |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C558899 | lopinavir-ritonavir drug combination |
Not provided
Not provided
Not provided