Optimizing reversal of HIV latency with combination therapy (pyrimethamine, lenalidomide, panobinostat)

Conditions

HIV-1

Brief summary

The fold change in cell-associated HIV-RNA at time points 6 and 24 hours as compared to baseline (time point 0 hour), The number and severity of clinical and biochemical adverse events considered by the investigator to be related to any of the investigational drugs.

Detailed description

1. The fold change in cell-associated HIV-RNA on LRA monotherapy components compared to combination LRA treatments., 2. The change in the HIV reservoir size and genetic composition from baseline to the end of the study., 3. The level of immune activation, and phenotype and functionality of the cellular immunity as compared from baseline to end of treatment., 4. The plasma concentrations of the investigational drugs during treatment., 5. Correlations of ex vivo and in-vivo cell associated HIV-RNA responses to the investigational drugs., 6. The association between clinical variables and the primary endpoints., 7. The number and frequency of measurable (above limit of detection or above limit of quantitation) plasma HIV-RNA during treatment., 8. Number of upward and downward counterfactuals

Related papers

No related papers found yet.

Interventions

DRUGPYRIMETHAMINE

DRUGLENALIDOMIDE

DRUGPANOBINOSTAT

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The fold change in cell-associated HIV-RNA at time points 6 and 24 hours as compared to baseline (time point 0 hour), The number and severity of clinical and biochemical adverse events considered by the investigator to be related to any of the investigational drugs.	—

Secondary

Measure	Time frame
1. The fold change in cell-associated HIV-RNA on LRA monotherapy components compared to combination LRA treatments., 2. The change in the HIV reservoir size and genetic composition from baseline to the end of the study., 3. The level of immune activation, and phenotype and functionality of the cellular immunity as compared from baseline to end of treatment., 4. The plasma concentrations of the investigational drugs during treatment., 5. Correlations of ex vivo and in-vivo cell associated HIV-RNA responses to the investigational drugs., 6. The association between clinical variables and the primary endpoints., 7. The number and frequency of measurable (above limit of detection or above limit of quantitation) plasma HIV-RNA during treatment., 8. Number of upward and downward counterfactuals	—

Measure

Time frame

1. The fold change in cell-associated HIV-RNA on LRA monotherapy components compared to combination LRA treatments., 2. The change in the HIV reservoir size and genetic composition from baseline to the end of the study., 3. The level of immune activation, and phenotype and functionality of the cellular immunity as compared from baseline to end of treatment., 4. The plasma concentrations of the investigational drugs during treatment., 5. Correlations of ex vivo and in-vivo cell associated HIV-RNA responses to the investigational drugs., 6. The association between clinical variables and the primary endpoints., 7. The number and frequency of measurable (above limit of detection or above limit of quantitation) plasma HIV-RNA during treatment., 8. Number of upward and downward counterfactuals

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Countries

Netherlands

Outcome results

None listed