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| Name | Class |
|---|---|
| Department of Disease Control, Thailand | UNKNOWN |
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The objective of this study is to determine efficacy of ritonavir-boosted lopinavir monotherapy as a maintenance regimen in HIV-1-infected patients who previously failed Non-nucleoside reverse transcriptase inhibitors (NNRTI) based regimens and currently received salvage protease-inhibitor (PI) based regimens.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Boosted lopinavir monotherapy | Experimental |
| |
| boosted lopinavir + optimized background regimens (OBRs) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ritonavir-boosted lopinavir | Drug | Lopinavir/ritonavir 200/50 mg every 12 hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to virological failure | virological failure was defined as having two consecutive results of HIV-1 RNA >400 copies/ml in time separated by 4 weeks | 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with virological suppression | virological suppression defined as having HIV-1 RNA <40 copies/ml | 48 weeks |
| Proportion of patients with virological failure | virological failure was defined as having two consecutive results of HIV-1 RNA >400 copies/ml in time separated by 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Krittaecho Siripassorn, MD | Bamrasnaradura Infectious Diseases Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bamrasnaradura Infectious Diseases Institute | Nonthaburi | 11000 | Thailand |
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| optimized background regimens (OBRs) | Drug | Optimized background regimens such as NRTIs, etravirine or raltegravir |
|
| 48 week |
| Time to loss of virological response (TLOVR) | TLOVR was defined as time between randomization and the last value that HIV-1 RNA <40 copies/ml in a patient who initially suppressed HIV-1 RNA but subsequently demonstrated virologic rebound (two consecutive HIV-1 RNA >40 copies/ml) | 48 weeks |
| Change of CD4 cells count | Change of CD4 cells count from start of study to Week 48 | 48 weeks |
| Adverse events | any grade 3 or grade 4 adverse events according to DAIDS AE grading table | 48 weeks |
| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| 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 |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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