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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-006448-23 | EudraCT Number |
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| Name | Class |
|---|---|
| NHS Health Technology Assessment Programme | OTHER |
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The PIVOT trial aims to determine whether a strategy of switching to PI monotherapy is non-inferior to continuing triple-therapy, in terms of the proportion of patients who maintain all the drug treatment options that were available to them at baseline after at least 3 years of follow-up, and to compare clinical events, safety, toxicity and health economic parameters between the two strategies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Protease Inhibitor Monotherapy | Experimental | Ritonavir-boosted protease inhibitor |
|
| Control | Active Comparator | Standard-of-care triple-therapy regimen |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Protease Inhibitor | Drug | Switch to a regimen comprising a single ritonavir-boosted Protease Inhibitor |
|
| Measure | Description | Time Frame |
|---|---|---|
| Loss of future drug options | The first occurrence of intermediate to high level resistance to any one or more of the standard antiretroviral drugs (limited to licensed drugs in contemporary use) to which the patient's virus was considered to be sensitive at trial entry (i.e. excluding drug resistance that was known to be present on previous resistance testing). | Up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Death from any cause | Up to 5 years | |
| Serious AIDS-defining illness | Up to 5 years | |
| Serious non-AIDS defining illness |
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Inclusion Criteria:
Vl < 50 for 24 weeks prior to screening CD4 > 100 at screening
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nick Paton, MD | Medical Research Council | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23646111 | Derived | Winston A, Arenas-Pinto A, Stohr W, Fisher M, Orkin CM, Aderogba K, De Burgh-Thomas A, O'Farrell N, Lacey CJ, Leen C, Dunn D, Paton NI; PIVOT Trial Team. Neurocognitive function in HIV infected patients on antiretroviral therapy. PLoS One. 2013 Apr 30;8(4):e61949. doi: 10.1371/journal.pone.0061949. Print 2013. |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000163 | Acquired Immunodeficiency Syndrome |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D015229 | Sexually Transmitted Diseases, Viral |
| D007154 | Immune System Diseases |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D012749 | Sexually Transmitted Diseases |
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| ID | Term |
|---|---|
| D011480 | Protease Inhibitors |
| ID | Term |
|---|---|
| D004791 | Enzyme Inhibitors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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| Standard-of-care Antiretroviral therapy | Drug | Regimen should consist of 3 drugs: 2 nucleoside reverse transcriptase inhibitors with either a non-nucleoside reverse transcriptase inhibitor or a protease inhibitor |
|
| Up to 5 years |
| Adverse events | Up to 5 years |
| Confirmed Virological rebound | Up to 5 years |
| CD4+ count change | Up to 5 years |
| Health-related Quality of Life change | Up to 5 years |
| Neurocognitive function change | Up to 5 years |
| Cardiovascular risk change | Up to 5 years |
| Health care costs | Up to 5 years |
| HIV VL in Genital Secretions | In a sub-set of participants (n=73):-
(Genital Secretions substudy REC # 09/H0305/58) | Week 96 |
| HIV VL in CSF | In a subset of participants on PI monotherapy (n=40).
(CNS substudy REC # 09/H0305/58). | Week 96 |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D012897 | Slow Virus Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |