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Current HIV treatment guidelines recommend a combination of drugs for the maintenance of antiretroviral therapy (ART). Simplification is considered critical to further scale-up of treatment, to support retention in care and to reduce costs. Dolutegravir is a once daily integrase inhibitor that shows very good tolerability, efficacy, and distinctive resistance profile. The researchers aim at investigating the feasibility of dolutegravir monotherapy in maintenance therapy. Briefly, 10 virologically suppressed patients for at least six months on conventional triple ART of dolutegravir plus two nucleoside reverse transcriptase inhibitors (NRTIs) will be switched to dolutegravir monotherapy for 24 weeks. The primary endpoint is the number of patients completing 24 weeks of dolutegravir monotherapy without experiencing virological failure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dolutegravir monotherapy | Experimental | 10 patients will be simplified to monotherapy of dolutegravir tablet 50mg once daily for 24 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dolutegravir | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients without virological failure defined as plasma HIV-1 RNA ≥ 200 copies/ml on two consecutive measurements or positive HIV-1 RNA level in cerebrospinal fluid (CSF) at week 24 or before | week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Quantification of the HIV-1 DNA reservoir in peripheral blood monocyte cells at baseline and week 24 | week 24 | |
| Emergence of genotypic resistance in plasma HIV-1 RNA in case of virological failure | week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in immune activation from baseline to week 24 measured by highly sensitive C-reactive protein (mg/l) | week 24 | |
| Change in immune activation from baseline to week 24 measured by cytokines (pg/ml) | week 24 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Delphine Sculier, MD | University Hospital, Geneva | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals of Geneva, HIV unit | Geneva | 1205 | Switzerland |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 25, 2019 | |
| Reset | Jul 12, 2019 | |
| Release | Jan 30, 2020 | |
| Reset | Feb 10, 2020 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 25, 2019 | Jul 12, 2019 | |||
| Jan 30, 2020 |
| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| ID | Term |
|---|---|
| C562325 | dolutegravir |
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| Quantification HIV-1 RNA levels in the CSF and semen at baseline and week 24 | Lumbar puncture is optional at baseline | week 24 |
| Change from baseline CD4 cell count from baseline at week 24 | week 24 |
| Adherence to medication at weeks 4, 8, 12, 16, 20, 24 | Number of participants with suboptimal adherence defined as more than 3 pills (10%) remaining from previous monthly visit OR missed more than one dose in a row OR missed dose more than once every two weeks | week 24 |
| Lipidic profile changes from baseline at week 24 | week 24 |
| Body fat composition as measured by dual energy x-ray absorptiometry (DXA) scan at baseline and week 24 | week 24 |
| Change in bone mineral density from baseline to week 24 | Number of patients with normal bone density, osteopenia or osteoporosis as defined by DXA scans results | week 24 |
| Change in immune activation from baseline to week 24 measured by d-dimers (microg/l) | week 24 |
| Feb 10, 2020 |
| 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 |