valproic acid has been researched along with HIV Infections in 44 studies
Valproic Acid: A fatty acid with anticonvulsant and anti-manic properties that is used in the treatment of EPILEPSY and BIPOLAR DISORDER. The mechanisms of its therapeutic actions are not well understood. It may act by increasing GAMMA-AMINOBUTYRIC ACID levels in the brain or by altering the properties of VOLTAGE-GATED SODIUM CHANNELS.
valproic acid : A branched-chain saturated fatty acid that comprises of a propyl substituent on a pentanoic acid stem.
HIV Infections: Includes the spectrum of human immunodeficiency virus infections that range from asymptomatic seropositivity, thru AIDS-related complex (ARC), to acquired immunodeficiency syndrome (AIDS).
| Excerpt | Relevance | Reference |
|---|---|---|
| " Given the limited evidence that resting CD4+ T cell infection (RCI) is affected by the histone deacetylase (HDAC) inhibitor valproic acid (VPA), we measured the stability of RCI and residual viremia in patients who added VPA with or without raltegravir (RAL), or enfuvirtide (ENF) with or without VPA, to standard ART." | 9.14 | Antiretroviral intensification and valproic acid lack sustained effect on residual HIV-1 viremia or resting CD4+ cell infection. ( Archin, NM; Bosch, RJ; Cheema, M; Coffin, JM; Cohen, M; Eron, J; Margolis, DM; Parker, D; Wiegand, A, 2010) |
| "A 30-year-old man with bipolar disorder and HIV initiated treatment with lopinavir/ritonavir, zidovudine, and lamivudine." | 7.73 | Possible interaction between lopinavir/ritonavir and valproic Acid exacerbates bipolar disorder. ( Allan, J; Brouillette, MJ; Delisle, MS; Sheehan, NL, 2006) |
| "A 42-year-old man with human immunodeficiency virus (HIV) infection and a history of complex partial seizures developed severe anemia after the addition of valproic acid to his stable antiretroviral regimen of zidovudine, lamivudine, and abacavir." | 7.72 | Severe anemia secondary to a probable drug interaction between zidovudine and valproic acid. ( Antoniou, T; Arbess, G; Gough, K; Yoong, D, 2004) |
| " Given the limited evidence that resting CD4+ T cell infection (RCI) is affected by the histone deacetylase (HDAC) inhibitor valproic acid (VPA), we measured the stability of RCI and residual viremia in patients who added VPA with or without raltegravir (RAL), or enfuvirtide (ENF) with or without VPA, to standard ART." | 5.14 | Antiretroviral intensification and valproic acid lack sustained effect on residual HIV-1 viremia or resting CD4+ cell infection. ( Archin, NM; Bosch, RJ; Cheema, M; Coffin, JM; Cohen, M; Eron, J; Margolis, DM; Parker, D; Wiegand, A, 2010) |
| " Key search terms included HIV, AIDS, seizures, valproic acid, and glutathione." | 4.80 | The use of valproic acid in HIV-positive patients. ( Jennings, HR; Romanelli, F, 1999) |
| "In a single-center pilot study, the size of the HIV reservoir of 11 patients receiving valproic acid for seizures for more than 2 years was compared with 13 matched patients." | 3.74 | Prolonged valproic acid treatment does not reduce the size of latent HIV reservoir. ( Aboulker, JP; Boufassa, F; Chaix, ML; Costagliola, D; Delfraissy, JF; Goujard, C; Lambotte, O; Lamine, A; Paller, C; Pallier, C; Sagot-Lerolle, N, 2008) |
| "A 30-year-old man with bipolar disorder and HIV initiated treatment with lopinavir/ritonavir, zidovudine, and lamivudine." | 3.73 | Possible interaction between lopinavir/ritonavir and valproic Acid exacerbates bipolar disorder. ( Allan, J; Brouillette, MJ; Delisle, MS; Sheehan, NL, 2006) |
| "Valproic acid (VPA) reduces latent human immunodeficiency virus (HIV) reservoirs by activating resting CD4+ cells." | 3.73 | Valproic acid does not affect markers of human immunodeficiency virus disease progression. ( Ances, BM; Buzzell, M; Ellis, RJ; Grant, I; Lazaretto, D; Letendre, S; Marcotte, TD; Marquie-Beck, J, 2006) |
| "A 42-year-old man with human immunodeficiency virus (HIV) infection and a history of complex partial seizures developed severe anemia after the addition of valproic acid to his stable antiretroviral regimen of zidovudine, lamivudine, and abacavir." | 3.72 | Severe anemia secondary to a probable drug interaction between zidovudine and valproic acid. ( Antoniou, T; Arbess, G; Gough, K; Yoong, D, 2004) |
| "Valproic acid treatment alone did not increase (CA US) HIV-1 RNA or augment the effect of pyrimethamine." | 3.30 | The BAF complex inhibitor pyrimethamine reverses HIV-1 latency in people with HIV-1 on antiretroviral therapy. ( Bax, HI; Burger, D; Colbers, A; Crespo, R; de Mendonça Melo, M; de Vries-Sluijs, TEMS; Gruters, RA; Hossain, T; Kan, TW; Katsikis, PD; Koch, BCP; Li, L; Lungu, C; Mahmoudi, T; Mesplède, T; Mueller, YM; Nouwen, JL; Overmars, RJ; Palstra, RJ; Papageorgiou, G; Prins, HAB; Rao, S; Rijnders, BJA; Rokx, C; Schurink, CAM; Stoszko, M; van de Vijver, DAMC; van Gorp, ECM; van Kampen, JJA; van Nood, E; Verbon, A, 2023) |
| "The dolutegravir/valproic acid drug-drug interaction (DDI) is suggested to be caused by protein displacement." | 3.01 | The dolutegravir/valproic acid drug-drug interaction is primarily based on protein displacement. ( Bax, H; Bollen, PDJ; Burger, DM; Colbers, A; de Mendonca Melo, M; de Vries-Sluijs, TEMS; Nouwen, J; Prins, HAB; Rijnders, BJA; Rokx, C; van Nood, E; Velthoven-Graafland, K; Verbon, A, 2021) |
| "Zidovudine is metabolized to an inactive 5'-glucuronide and has a short plasma half-life requiring frequent dosing." | 2.67 | Pharmacokinetic interaction between zidovudine and valproic acid in patients infected with human immunodeficiency virus. ( Agrawal, KC; Akula, S; George, WJ; Greenspan, DL; Hyslop, NE; Lertora, JJ; Rege, AB, 1994) |
| "Seizures were treated with sodium valproate (n = 11), phenobarbital (n = 3), diazepam (n = 2), lamotrigine (n = 1), and carbamazepine (n = 1)." | 1.39 | Prevalence of seizures in children infected with human immunodeficiency virus. ( Eley, B; Petersen, R; Samia, P; Walker, KG; Wilmshurst, JM, 2013) |
| "Recurrent seizures may occur in up to 11% of HIV positive patients." | 1.37 | Sodium valproate and highly active antiretroviral therapy in HIV positive patients who develop new onset seizures. ( Bhigjee, AI; Moodley, P; Parboosing, R; Yacoob, Y, 2011) |
| "Among 1345 HIV/AIDS persons in active care between 2001 and 2007, 169 individuals were exposed to AEDs for the following indications: peripheral neuropathy/neuropathic pain (60%), seizure/epilepsy (24%), mood disorder (13%) and movement disorder (2%)." | 1.36 | Clinical outcomes and immune benefits of anti-epileptic drug therapy in HIV/AIDS. ( Gill, MJ; Krentz, HB; Lee, K; Maingat, F; Power, C; Siemieniuk, RA; Vivithanaporn, P, 2010) |
| "Low-level viremia was quantitated by single copy plasma HIV RNA assay." | 1.35 | Valproic acid without intensified antiviral therapy has limited impact on persistent HIV infection of resting CD4+ T cells. ( Archin, NM; Bandarenko, N; Bosch, RJ; Coffin, JM; Eron, JJ; Hartmann-Duff, A; Landay, AL; Margolis, DM; Martinson, JA; Palmer, S; Schmitz, JL; Wiegand, A, 2008) |
| " The subjects had 11 plasma samples drawn over a dosing interval on days 1, 15, and 30." | 1.35 | Effects of minocycline and valproic acid coadministration on atazanavir plasma concentrations in human immunodeficiency virus-infected adults receiving atazanavir-ritonavir. ( Cruttenden, K; DiCenzo, R; Gelbard, H; Hochreiter, J; Mariuz, P; Peterson, DR; Rezk, NL; Schifitto, G, 2008) |
| "Valproic acid (VPA) has the potential to benefit patients suffering from human immunodeficiency virus (HIV)-associated cognitive impairment." | 1.32 | Effects of valproic acid coadministration on plasma efavirenz and lopinavir concentrations in human immunodeficiency virus-infected adults. ( Cruttenden, K; DiCenzo, R; Gelbard, H; Morse, G; Peterson, D; Riggs, G; Schifitto, G, 2004) |
| "Seizures are common in patients infected with human immunodeficiency virus (HIV)." | 1.30 | Elevated free phenytoin and free valproic acid concentrations in sera of patients infected with human immunodeficiency virus. ( Dasgupta, A; McLemore, JL, 1998) |
| Timeframe | Studies, this research(%) | All Research% |
|---|---|---|
| pre-1990 | 0 (0.00) | 18.7374 |
| 1990's | 4 (9.09) | 18.2507 |
| 2000's | 22 (50.00) | 29.6817 |
| 2010's | 15 (34.09) | 24.3611 |
| 2020's | 3 (6.82) | 2.80 |
| Authors | Studies |
|---|---|
| Prins, HAB | 2 |
| Crespo, R | 1 |
| Lungu, C | 1 |
| Rao, S | 1 |
| Li, L | 1 |
| Overmars, RJ | 1 |
| Papageorgiou, G | 1 |
| Mueller, YM | 1 |
| Stoszko, M | 1 |
| Hossain, T | 1 |
| Kan, TW | 1 |
| Rijnders, BJA | 2 |
| Bax, HI | 1 |
| van Gorp, ECM | 1 |
| Nouwen, JL | 1 |
| de Vries-Sluijs, TEMS | 2 |
| Schurink, CAM | 1 |
| de Mendonça Melo, M | 2 |
| van Nood, E | 2 |
| Colbers, A | 2 |
| Burger, D | 1 |
| Palstra, RJ | 1 |
| van Kampen, JJA | 1 |
| van de Vijver, DAMC | 1 |
| Mesplède, T | 1 |
| Katsikis, PD | 1 |
| Gruters, RA | 1 |
| Koch, BCP | 1 |
| Verbon, A | 2 |
| Mahmoudi, T | 1 |
| Rokx, C | 2 |
| Calcagno, A | 2 |
| Cusato, J | 1 |
| Ferrara, M | 1 |
| De Nicolò, A | 2 |
| Lazzaro, A | 1 |
| Manca, A | 1 |
| D'Avolio, A | 2 |
| Di Perri, G | 2 |
| Bonora, S | 2 |
| Bollen, PDJ | 1 |
| Velthoven-Graafland, K | 1 |
| Nouwen, J | 1 |
| Bax, H | 1 |
| Burger, DM | 1 |
| Palazzo, A | 1 |
| Trunfio, M | 1 |
| Pirriatore, V | 1 |
| Milesi, M | 1 |
| Alcantarini, C | 1 |
| Crosby, B | 1 |
| Deas, CM | 1 |
| Tseng, AL | 1 |
| Wong, AYJ | 1 |
| McLelland, CJ | 1 |
| Walmsley, SL | 1 |
| Davidson, DC | 2 |
| Schifitto, G | 5 |
| Maggirwar, SB | 2 |
| Guzmán-Sánchez, D | 1 |
| Asz-Sigall, D | 1 |
| Sagot-Lerolle, N | 1 |
| Lamine, A | 1 |
| Chaix, ML | 1 |
| Boufassa, F | 1 |
| Aboulker, JP | 1 |
| Costagliola, D | 1 |
| Goujard, C | 1 |
| Pallier, C | 1 |
| Paller, C | 1 |
| Delfraissy, JF | 1 |
| Lambotte, O | 1 |
| Archin, NM | 3 |
| Eron, JJ | 1 |
| Palmer, S | 1 |
| Hartmann-Duff, A | 1 |
| Martinson, JA | 1 |
| Wiegand, A | 2 |
| Bandarenko, N | 1 |
| Schmitz, JL | 1 |
| Bosch, RJ | 3 |
| Landay, AL | 1 |
| Coffin, JM | 2 |
| Margolis, DM | 3 |
| DiCenzo, R | 2 |
| Peterson, DR | 2 |
| Cruttenden, K | 3 |
| Mariuz, P | 1 |
| Rezk, NL | 1 |
| Hochreiter, J | 1 |
| Gelbard, H | 3 |
| Desai, J | 1 |
| Terbach, N | 1 |
| Williams, RS | 1 |
| Cheema, M | 1 |
| Parker, D | 1 |
| Eron, J | 1 |
| Cohen, M | 1 |
| Zachary, D | 1 |
| Shekar, A | 1 |
| Letourneau, C | 1 |
| Neill, M | 1 |
| Lee, K | 1 |
| Vivithanaporn, P | 1 |
| Siemieniuk, RA | 1 |
| Krentz, HB | 1 |
| Maingat, F | 1 |
| Gill, MJ | 1 |
| Power, C | 1 |
| Yacoob, Y | 1 |
| Bhigjee, AI | 1 |
| Moodley, P | 1 |
| Parboosing, R | 1 |
| Saunders, KO | 1 |
| Ward-Caviness, C | 1 |
| Schutte, RJ | 1 |
| Freel, SA | 1 |
| Overman, RG | 1 |
| Thielman, NM | 1 |
| Cunningham, CK | 1 |
| Kepler, TB | 1 |
| Tomaras, GD | 1 |
| Hirschman, MP | 1 |
| Spinelli, SL | 1 |
| Morrell, CN | 1 |
| Phipps, RP | 1 |
| Sahu, GK | 1 |
| Cloyd, MW | 1 |
| Routy, JP | 1 |
| Tremblay, CL | 1 |
| Angel, JB | 1 |
| Trottier, B | 1 |
| Rouleau, D | 1 |
| Baril, JG | 1 |
| Harris, M | 1 |
| Trottier, S | 1 |
| Singer, J | 1 |
| Chomont, N | 1 |
| Sékaly, RP | 1 |
| Boulassel, MR | 1 |
| Blazkova, J | 1 |
| Chun, TW | 1 |
| Belay, BW | 1 |
| Murray, D | 1 |
| Justement, JS | 1 |
| Funk, EK | 1 |
| Nelson, A | 1 |
| Hallahan, CW | 1 |
| Moir, S | 1 |
| Wender, PA | 1 |
| Fauci, AS | 1 |
| Samia, P | 1 |
| Petersen, R | 1 |
| Walker, KG | 1 |
| Eley, B | 1 |
| Wilmshurst, JM | 1 |
| Antoniou, T | 1 |
| Gough, K | 1 |
| Yoong, D | 1 |
| Arbess, G | 1 |
| Ylisastigui, L | 1 |
| Lehrman, G | 1 |
| Peterson, D | 1 |
| Morse, G | 1 |
| Riggs, G | 1 |
| Cohen, J | 1 |
| Sheehan, NL | 1 |
| Brouillette, MJ | 1 |
| Delisle, MS | 1 |
| Allan, J | 1 |
| Siliciano, JM | 1 |
| Siliciano, RF | 2 |
| Zhong, J | 1 |
| Ni, H | 1 |
| Gaugh, M | 1 |
| Gendelman, HE | 1 |
| Boska, M | 1 |
| Steel, A | 1 |
| Clark, S | 1 |
| Teo, I | 1 |
| Shaunak, S | 1 |
| Nelson, M | 1 |
| Gazzard, B | 1 |
| Kelleher, P | 1 |
| Saraga, M | 1 |
| Preisig, M | 1 |
| Zullino, DF | 1 |
| Ances, BM | 2 |
| Letendre, S | 1 |
| Buzzell, M | 1 |
| Marquie-Beck, J | 1 |
| Lazaretto, D | 1 |
| Marcotte, TD | 1 |
| Grant, I | 1 |
| Ellis, RJ | 2 |
| Cysique, LA | 1 |
| Maruff, P | 1 |
| Brew, BJ | 1 |
| Schooley, RT | 1 |
| Mellors, JW | 1 |
| Siliciano, JD | 1 |
| Lai, J | 1 |
| Callender, M | 1 |
| Pitt, E | 1 |
| Zhang, H | 1 |
| Margolick, JB | 1 |
| Gallant, JE | 1 |
| Cofrancesco, J | 1 |
| Moore, RD | 1 |
| Gange, SJ | 1 |
| Maggi, JD | 1 |
| Halman, MH | 1 |
| Letendre, SL | 1 |
| Alexander, T | 1 |
| Lertora, JJ | 1 |
| Rege, AB | 1 |
| Greenspan, DL | 1 |
| Akula, S | 1 |
| George, WJ | 1 |
| Hyslop, NE | 1 |
| Agrawal, KC | 1 |
| Dasgupta, A | 1 |
| McLemore, JL | 1 |
| Hardy, MA | 1 |
| Nardacci, D | 1 |
| Jennings, HR | 1 |
| Romanelli, F | 1 |
| Walker, UA | 1 |
| Venhoff, N | 1 |
| Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
|---|---|---|---|---|---|---|---|
| LRAs United as a Novel Anti-HIV Strategy (LUNA): a Randomized Controlled Trial.[NCT03525730] | Phase 1/Phase 2 | 28 participants (Actual) | Interventional | 2018-04-18 | Completed | ||
| IGHID 11424 - A Pilot Trial of the Effect of Vorinostat and AGS-004 on Persistent HIV-1 Infection (The VOR VAX Study)[NCT02707900] | Phase 1 | 6 participants (Actual) | Interventional | 2016-03-31 | Terminated (stopped due to Manufacturing of the AGS-004 HIV vaccine by Argos could no longer be provided.) | ||
| IGHID 1309 -A Phase I Study to Evaluate the Kinetics of the Immunologic Response and Virologic Impact of AGS-004 in HIV-Infected Individuals Suppressed on Antiretroviral Therapy Initiated During Acute and Chronic HIV Infection[NCT02042248] | Phase 1 | 6 participants (Actual) | Interventional | 2014-03-31 | Completed | ||
| IGHID 1320 - A Phase I Study to Evaluate the Safety, Immunologic, and Virologic Responses of HIV-1 Antigen Expanded Specific T Cell Therapy (HXTC) as a Therapeutic Strategy in HIV-Infected Individuals Started on Antiretroviral Therapy During Acute and Chr[NCT02208167] | Phase 1 | 6 participants (Actual) | Interventional | 2015-04-07 | Completed | ||
| IGHID 11417 - The Safety and Efficacy of Fixed Dose Combination Dolutegravir/Abacavir/Lamivudine FDC Initiated During Acute HIV Infection: Impact on the Latent HIV Reservoir and Long-Term Immunologic Effect[NCT02384395] | 40 participants (Actual) | Interventional | 2015-09-30 | Completed | |||
| Research In Viral Eradication of HIV Reservoirs[NCT02336074] | Phase 2 | 60 participants (Actual) | Interventional | 2015-11-27 | Completed | ||
| 10493 - MK-0518 Intensification and HDAC Inhibition in Depletion of Resting CD4+ T Cell HIV Infection[NCT00614458] | Phase 2 | 6 participants (Actual) | Interventional | 2007-04-30 | Terminated (stopped due to Due to insufficient funds) | ||
| Use of Valproic Acid to Purge HIV From Resting CD4+ Memory Cells/ A Proof-of-concept Study[NCT00289952] | Phase 2 | 50 participants (Anticipated) | Interventional | 2006-06-30 | Completed | ||
| A Phase I/II Study of Romidepsin in HIV-Infected Adults With Suppressed Viremia on Antiretroviral Therapy to Assess Safety, Tolerability, and Activation of HIV-1 Expression[NCT01933594] | Phase 1/Phase 2 | 59 participants (Actual) | Interventional | 2014-05-05 | Completed | ||
| Inhibiting Histone Deacetylase: Toward Eradication of HIV[NCT00312546] | Phase 1 | 14 participants (Actual) | Interventional | 2006-06-30 | Terminated | ||
| The Effects of Valproic Acid on Zidovudine Glucuronidation and Pharmacokinetics in HIV-Infected Patients.[NCT00000629] | Phase 1 | 6 participants | Interventional | Completed | |||
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] | |||||||
(NCT02384395)
Timeframe: Baseline, Week 24
| Intervention | copies/mL (Median) |
|---|---|
| DTG/3TC/ABC FDC | -590211 |
Sign/symptom, lab toxicity, or clinical events, or Grade 3 or higher AE that is definitely, probably, or possibly related to study treatment (NCT02384395)
Timeframe: Baseline through Week 96
| Intervention | Participants (Count of Participants) |
|---|---|
| DTG/3TC/ABC FDC | 1 |
Total number of participants on study at Week 24 with an HIV-1 RNA level less than 200 copies/mL (NCT02384395)
Timeframe: Week 24
| Intervention | Participants (Count of Participants) |
|---|---|
| DTG/3TC/ABC FDC | 34 |
Proportion of participants completing Week 48 with an HIV-1 RNA level less than 50 copies/mL (NCT02384395)
Timeframe: Week 48
| Intervention | proportion of participants (Number) |
|---|---|
| DTG/3TC/ABC FDC | 0.88 |
Histone H4 acetylation using a H4K5/8/12/16 immunoassay with thawed PBMC derived cell lysates added to an ELISA using anti-H4 monoclonal antibody (NCT02336074)
Timeframe: 12 weeks
| Intervention | Fold increase pre to post vorinostat (Mean) |
|---|---|
| Intervention (Arm B - ART + Vaccines + Vorinostat) | 3.19 |
Number of Participants with undetectable quantitative viral outgrowth (NCT02336074)
Timeframe: At week 16
| Intervention | Participants with undetectable outgrowth (Number) |
|---|---|
| Control (Arm A - ART Only) | 12 |
| Intervention (Arm B - ART + Vaccines + Vorinostat) | 6 |
The average of two measures taken at post-randomisation week 16 and 18 (NCT02336074)
Timeframe: Averaged across post-randomisation week 16 and 18
| Intervention | HIV-DNA copies/mill CD4+ T cells (log10) (Mean) |
|---|---|
| Control (Arm A - ART Only) | 2.95 |
| Intervention (Arm B - ART + Vaccines + Vorinostat) | 3.06 |
"CD8+ T cell antiviral suppressive activity was expressed as percentage elimination and determined as follows: [(fraction of p24+ cells in CD4+ T cells cultured alone) - (fraction of p24 + in CD4+ T cells cultured with CD8+ cells)]/(fraction of p24+ cells in CD4+ T cells cultured alone) × 100.~Viral inhibition Assay" (NCT02336074)
Timeframe: 12 weeks
| Intervention | Percentage elimination (Mean) |
|---|---|
| Control (Arm A - ART Only) | -18.25 |
| Intervention (Arm B - ART + Vaccines + Vorinostat) | 1.50 |
Percentage of CD8+ CD107a+ IFNγ+ T cells , assessed using an optimized and qualified flow cytometry panel. (NCT02336074)
Timeframe: 12 weeks
| Intervention | % cells CD8+ CD107a+ IFNγ+ (Median) | |
|---|---|---|
| Post randomisation week 9 | Post randomisation week 12 | |
| Control (Arm A - ART Only) | 0.052 | 0.062 |
| Intervention (Arm B - ART + Vaccines + Vorinostat) | 0.194 | 0.263 |
Percentage of CD4+ CD154+ IFNγ+ T cells , assessed using an optimized and qualified flow cytometry panel. (NCT02336074)
Timeframe: 12 weeks
| Intervention | % cells CD4+ CD154+ IFNγ+ (Median) | |
|---|---|---|
| Post randomisation week 9 | Post randomisation week 12 | |
| Control (Arm A - ART Only) | 0.006 | 0.006 |
| Intervention (Arm B - ART + Vaccines + Vorinostat) | 0.097 | 0.109 |
A change in infected cells from prior to the initiation of VPA and MK0518 to after 20 weeks of treatment. (NCT00614458)
Timeframe: 20 weeks
| Intervention | infected cells /million cells (Median) |
|---|---|
| Effect on Latent HIV of Adding Raltegravir and VPA to ART | 0.390 |
Baseline is defined as the pre-entry value. Change was calculated as the value at 72 hours after the second administration of Romidepsin or placebo (at day 14) minus the value at baseline. (NCT01933594)
Timeframe: Pre-entry and 72 hours after the second administration of Romidepsin or placebo (at day 14)
| Intervention | log10 copies/mL (Median) |
|---|---|
| Cohort 4-Arm 4A (Romidepsin) | -0.26 |
| Cohort 4-Arm 4B (Placebo for Romidepsin) | -0.16 |
Baseline is defined as the pre-entry value. Change was calculated as the value at 14 days after administration of Romidepsin or placebo (at entry) minus the value at baseline. (NCT01933594)
Timeframe: Pre-entry and 14 days after the administration of RMD or placebo (at entry)
| Intervention | log10 copies/mL (Median) |
|---|---|
| Cohorts 1-3 (Romidepsin) | 0.02 |
| Cohorts 1-3 (Placebo for Romidepsin) | -0.05 |
Baseline is defined as the pre-entry value. Change was calculated as the value at 24 hours after administration of Romidepsin or placebo (at entry) minus the value at baseline. (NCT01933594)
Timeframe: Pre-entry and 24 hours after the single administration of Romidepsin or placebo (at entry)
| Intervention | log10 (copies/10^6 resting CD4 cells) (Median) |
|---|---|
| Cohorts 1-3 (Romidepsin) | -.009 |
| Cohorts 1-3 (Placebo for Romidepsin) | 0 |
"Baseline is defined as the value at Hour 0, right before the single administration of Romidepsin or placebo.~Change was calculated as the value at 24 hours after administration of Romidepsin or placebo (at entry) minus the value at baseline.~Median Fluorescent Intensity (MFI) data describes a shift in the expression of a fluorescently labeled marker on a population of cells. The reported MFI is an arbitrary value dependent on the voltage applied to the corresponding flow cytometer detector." (NCT01933594)
Timeframe: Hour 0 and 24 hours after the single administration of RMD or placebo (at entry)
| Intervention | arbitrary units (Median) |
|---|---|
| Cohorts 1-3 (Romidepsin) | -7 |
| Cohorts 1-3 (Placebo for Romidepsin) | -194 |
Baseline is defined as the average of the pre-entry and entry values. Change was calculated as the value at 72 hours after the second administration of Romidepsin or placebo (at day 14) minus the value at baseline. (NCT01933594)
Timeframe: Pre-entry, entry and 72 hours after the second administration of Romidepsin or placebo (at day 14)
| Intervention | log10 copies/mL (Median) |
|---|---|
| Cohort 4-Arm 4A (Romidepsin) | 0 |
| Cohort 4-Arm 4B (Placebo for Romidepsin) | 0.82 |
"Baseline is defined as the average of the pre-entry and entry values. Hour 24/48 is defined as the average of values at 24 and 48 hours after the single administration of Romidepsin or placebo (at study entry).~Change was calculated as the value at hour 24/48 minus the value at baseline." (NCT01933594)
Timeframe: Pre-entry, entry, 24 and 48 hours after the single administration of Romidepsin or placebo (at entry)
| Intervention | log10 copies/mL (Median) |
|---|---|
| Cohorts 1-3 (Romidepsin) | 0.12 |
| Cohorts 1-3 (Placebo for Romidepsin) | 0.12 |
Number of participants with reported grade 2-4 adverse events including signs/symptoms, lab toxicities, and clinical events that are at least possibly related to study treatment. The DAIDS AE Grading Table (Version 1.0) was used. (NCT01933594)
Timeframe: Measured from study entry to off study
| Intervention | Participants (Count of Participants) |
|---|---|
| Cohort 4-Arm 4A (Romidepsin) | 5 |
| Cohort 4-Arm 4B (Placebo for Romidepsin) | 0 |
Number of participants with reported grade 2-4 adverse events including signs/symptoms, lab toxicities, and clinical events that are at least possibly related to study treatment. The DAIDS AE Grading Table (Version 1.0) was used. (NCT01933594)
Timeframe: Measured from study entry to off study
| Intervention | Participants (Count of Participants) |
|---|---|
| Cohort 1-Arm 1A (Romidepsin) | 4 |
| Cohort 2-Arm 2A (Romidepsin) | 2 |
| Cohort 3-Arm 3A (Romidepsin) | 1 |
| Cohorts 1-3 (Placebo for Romidepsin) | 1 |
Proportion of participants with Grade 3 or Higher Adverse Events (AEs) in Cohort 4 Romidepsin Arm, including signs/symptoms, lab toxicities, and /or clinical events probably, possibly, or definitely related to study treatment (as judged by the core team, blinded to treatment arm). The DAIDS AE Grading Table (Version 1.0) was used. (NCT01933594)
Timeframe: Measured from the time of the first Romidepsin administration through 28 days after the last administration (at day 42)
| Intervention | proportion of participants (Number) |
|---|---|
| Cohort 4-Arm 4A (Romidepsin) | 0.077 |
Proportion of participants with Grade 3 or higher adverse events (AEs) in Cohorts 1-3 Romidepsin Arms, including signs/symptoms, lab toxicities, and /or clinical events probably, possibly, or definitely related to study treatment (as judged by the core team, blinded to treatment arm). The DAIDS AE Grading Table (Version 1.0) was used. (NCT01933594)
Timeframe: Measured from the time of Romidepsin administration (at entry) until 28 days after the administration
| Intervention | proportion of participants (Number) |
|---|---|
| Cohorts 1-3 (Romidepsin) | 0 |
Baseline is defined as the average of the pre-entry and entry values. Change was calculated as the value at 24 hours post each administration of Romidepsin or placebo (at entry, and days 14, 28 and 42) and 2, 5, 10 and 18 weeks post the fourth administration minus the value at baseline (NCT01933594)
Timeframe: Pre-entry, entry, 24 hours after each administration of Romidepsin or placebo (at entry, and days 14, 28 and 42), and 2, 5, 10 and 18 weeks after the fourth administration (at day 42)
| Intervention | percentage of CD4 cells (Median) | |||||||
|---|---|---|---|---|---|---|---|---|
| Change from baseline to 24 hours post infusion 1 | Change from baseline to 24 hours post infusion 2 | Change from baseline to 24 hours post infusion 3 | Change from baseline to 24 hours post infusion 4 | Change from baseline to 2 weeks post infusion 4 | Change from baseline to 5 weeks post infusion 4 | Change from baseline to 10 weeks post infusion 4 | Change from baseline to 18 weeks post infusion 4 | |
| Cohort 4-Arm 4A (Romidepsin) | -2.5 | -4.5 | -3.5 | -4.5 | -0.5 | -1.8 | -2.8 | -0.5 |
| Cohort 4-Arm 4B (Placebo for Romidepsin) | -2 | 0.5 | 1 | 0.5 | -0.5 | 0 | -0.5 | -2.5 |
Baseline is defined as the average of the pre-entry and entry values. Change was calculated as the value at 24 hours after each administration of Romidepsin or placebo (at entry, and days 14, 28 and 42) minus the value at baseline. (NCT01933594)
Timeframe: Pre-entry, entry and 24 hours after each administration of Romidepsin or placebo (at entry, and days 14, 28 and 42)
| Intervention | log10 (copies/10^6 PBMCs) (Median) | |||
|---|---|---|---|---|
| Change from baseline to 24 hours post infusion 1 | Change from baseline to 24 hours post infusion 2 | Change from baseline to 24 hours post infusion 3 | Change from baseline to 24 hours post infusion 4 | |
| Cohort 4-Arm 4A (Romidepsin) | -0.06 | -0.07 | -0.44 | -0.05 |
| Cohort 4-Arm 4B (Placebo for Romidepsin) | -0.16 | -0.52 | -0.02 | -0.3 |
Baseline is defined as the average of the two pre-entry values. Change was calculated as the value at 24 hours post first and fourth administration of Romidepsin or placebo (at entry and day 42) and 10 weeks post the fourth administration (at day 42) minus the value at baseline. (NCT01933594)
Timeframe: Pre-entry, 24 hours after the first and fourth administration of Romidepsin or placebo (at entry and day 42), and 10 weeks after the fourth administration (at day 42)
| Intervention | percentage of CD4 cells (Median) | ||
|---|---|---|---|
| Change from baseline to 24 hours post infusion 1 | Change from baseline to 24 hours post infusion 4 | Change from baseline to 10 weeks post infusion 4 | |
| Cohort 4-Arm 4A (Romidepsin) | 0.2 | 1 | 0.4 |
| Cohort 4-Arm 4B (Placebo for Romidepsin) | 0.5 | 2 | 0.7 |
"Baseline is defined as the value at hour 0, where hour 0 is right before the single administration of Romidepsin or placebo (at entry).~Change was calculated as the value at 48 hours, 7 days and 28 days after the single administration of Romidepsin or placebo minus the value at baseline." (NCT01933594)
Timeframe: Hour 0 and 48 hours, 7 days and 28 days after the single administration of Romidepsin or placebo (at entry)
| Intervention | percentage of CD4 cells (Median) | ||
|---|---|---|---|
| Change from baseline to 48 hours post infusion | Change from baseline to 7 days post infusion | Change from baseline to 28 days post infusion | |
| Cohorts 1-3 (Placebo for Romidepsin) | 0.4 | -1 | -1.4 |
| Cohorts 1-3 (Romidepsin) | 0.5 | 1 | 1.2 |
Baseline is defined as the average of the two pre-entry values. Change was calculated as the value at 24 hours post first and fourth administration of Romidepsin or placebo (at entry and day 42) and 10 weeks post the fourth administration (at day 42) minus the value at baseline. (NCT01933594)
Timeframe: Pre-entry, 24 hours after the first and fourth administration of Romidepsin or placebo (at entry and day 42), and 10 weeks after the fourth administration (at day 42)
| Intervention | percentage of CD8 cells (Median) | ||
|---|---|---|---|
| Change from baseline to 24 hours post infusion 1 | Change from baseline to 24 hours post infusion 4 | Change from baseline to 10 weeks post infusion 4 | |
| Cohort 4-Arm 4A (Romidepsin) | 0.6 | 1.1 | -0.3 |
| Cohort 4-Arm 4B (Placebo for Romidepsin) | 0.2 | 1.1 | 2.8 |
"Baseline is defined as the value at hour 0, where hour 0 is right before the single administration of Romidepsin or placebo (at entry).~Change was calculated as the value at 48 hours, 7 days and 28 days after the single administration of Romidepsin or placebo minus the value at baseline." (NCT01933594)
Timeframe: Hour 0 and 48 hours, 7 days and 28 days after the single administration of Romidepsin or placebo (at entry)
| Intervention | percentage of CD8 cells (Median) | ||
|---|---|---|---|
| Change from baseline to 48 hours post infusion | Change from baseline to 7 days post infusion | Change from baseline to 28 days post infusion | |
| Cohorts 1-3 (Placebo for Romidepsin) | 0.3 | -1.3 | -0.1 |
| Cohorts 1-3 (Romidepsin) | 0.1 | 0.8 | 0.3 |
Baseline is defined as the average of the two pre-entry values. Change was calculated as the value at 24 hours post first and fourth administration of Romidepsin or placebo (at etnry and day 42) and 10 weeks post the fourth administration (at day 42) minus the value at baseline. (NCT01933594)
Timeframe: Pre-entry, 24 hours after the first and fourth administration of Romidepsin or placebo (at etnry and day 42), and 10 weeks after the fourth administration (at day 42)
| Intervention | percentage of CD4 cells (Median) | ||
|---|---|---|---|
| Change from baseline to 24 hours post infusion 1 | Change from baseline to 24 hours post infusion 4 | Change from baseline to 10 weeks post infusion 4 | |
| Cohort 4-Arm 4A (Romidepsin) | 0 | 0 | 0 |
| Cohort 4-Arm 4B (Placebo for Romidepsin) | -0.1 | -0.1 | -0.1 |
"Baseline is defined as the value at hour 0, where hour 0 is right before the single administration of Romidepsin or placebo (at entry).~Change was calculated as the value at 48 hours, 7 days and 28 days after the single administration of Romidepsin or placebo minus the value at baseline." (NCT01933594)
Timeframe: Hour 0 and 48 hours, 7 days and 28 days after the single administration of Romidepsin or placebo (at entry)
| Intervention | percentage of CD4 cells (Median) | ||
|---|---|---|---|
| Change from baseline to 48 hours post infusion | Change from baseline to 7 days post infusion | Change from baseline to 28 days post infusion | |
| Cohorts 1-3 (Placebo for Romidepsin) | 0 | 0 | 0 |
| Cohorts 1-3 (Romidepsin) | 0 | 0 | 0 |
Baseline is defined as the average of the two pre-entry values. Change was calculated as the value at 24 hours post first and fourth administration of Romidepsin or placebo (at etnry and day 42) and 10 weeks post the fourth administration (at day 42) minus the value at baseline. (NCT01933594)
Timeframe: Pre-entry, 24 hours after the first and fourth administration of Romidepsin or placebo (at etnry and day 42), and 10 weeks after the fourth administration (at day 42
| Intervention | percentage of CD8 cells (Median) | ||
|---|---|---|---|
| Change from baseline to 24 hours post infusion 1 | Change from baseline to 24 hours post infusion 4 | Change from baseline to 10 weeks post infusion 4 | |
| Cohort 4-Arm 4A (Romidepsin) | 0 | 0 | 0 |
| Cohort 4-Arm 4B (Placebo for Romidepsin) | 0 | -0.1 | 0 |
"Baseline is defined as the value at hour 0, where hour 0 is right before the single administration of Romidepsin or placebo (at entry).~Change was calculated as the value at 48 hours, 7 days and 28 days after the single administration of Romidepsin or placebo minus the value at baseline." (NCT01933594)
Timeframe: Hour 0 and 48 hours, 7 days and 28 days after the single administration of Romidepsin or placebo (at entry)
| Intervention | percentage of CD8 cells (Median) | ||
|---|---|---|---|
| Change from baseline to 48 hours post infusion | Change from baseline to 7 days post infusion | Change from baseline to 28 days post infusion | |
| Cohorts 1-3 (Placebo for Romidepsin) | 0 | 0 | 0 |
| Cohorts 1-3 (Romidepsin) | 0 | 0 | 0 |
"Baseline is defined as the value right before the first administration of Romidepsin or placebo (at entry).~Change was calculated as the value at 24 hours after each administration of Romidepsin or placebo (at entry, and days 14, 28 and 42) and 72 hours after the second administration minus the value at baseline.~Median Fluorescent Intensity (MFI) data describes a shift in the expression of a fluorescently labeled marker on a population of cells. The reported MFI is an arbitrary value dependent on the voltage applied to the corresponding flow cytometer detector." (NCT01933594)
Timeframe: Entry, 24 hours after each administration of Romidepsin or placebo (at entry, and days 14, 28 and 42), and 72 hours after the second administration (at day 14)
| Intervention | arbitrary units (Median) | ||||
|---|---|---|---|---|---|
| Change from baseline to 24 hours post infusion 1 | Change from baseline to 24 hours post infusion 2 | Change from baseline to 72 hours post infusion 2 | Change from baseline to 24 hours post infusion 3 | Change from baseline to 24 hours post infusion 4 | |
| Cohort 4-Arm 4A (Romidepsin) | 2402 | 2774 | 4741 | 4522 | 4342 |
| Cohort 4-Arm 4B (Placebo for Romidepsin) | 749 | 8497 | 4741 | 5665 | 2697 |
Baseline is defined as the average of the two pre-entry values. Change was calculated as the value at 24 hours post first and fourth administration of Romidepsin or placebo (at entry and day 42) and 10 weeks post the fourth administration (at day 42) minus the value at baseline. (NCT01933594)
Timeframe: Pre-entry, 24 hours after the first and fourth administration of Romidepsin or placebo (at entry and day 42), and 10 weeks after the fourth administration (at day 42)
| Intervention | percentage of CD4 cells (Median) | ||
|---|---|---|---|
| Change from baseline to 24 hours post infusion 1 | Change from baseline to 24 hours post infusion 4 | Change from baseline to 10 weeks post infusion 4 | |
| Cohort 4-Arm 4A (Romidepsin) | 0.5 | -2 | 0.3 |
| Cohort 4-Arm 4B (Placebo for Romidepsin) | -1.4 | 0.9 | 0.1 |
"Baseline is defined as the value at hour 0, where hour 0 is right before the single administration of Romidepsin or placebo (at entry).~Change was calculated as the value at 48 hours, 7 days and 28 days after the single administration of Romidepsin or placebo (at entry) minus the value at baseline." (NCT01933594)
Timeframe: Hour 0 and 48 hours, 7 days and 28 days after the single administration of Romidepsin or placebo (at entry)
| Intervention | percentage of CD4 cells (Median) | ||
|---|---|---|---|
| Change from baseline to 48 hours post infusion | Change from baseline to 7 days post infusion | Change from baseline to 28 days post infusion | |
| Cohorts 1-3 (Placebo for Romidepsin) | 1.2 | 0 | -1.3 |
| Cohorts 1-3 (Romidepsin) | 0.2 | 0.6 | 1.2 |
Baseline is defined as the average of the two pre-entry values. Change was calculated as the value at 24 hours post first and fourth administration of Romidepsin or placebo (at entry and day 42) and 10 weeks post the fourth administration (at day 42) minus the value at baseline. (NCT01933594)
Timeframe: Pre-entry, 24 hours after the first and fourth administration of Romidepsin or placebo (at entry and day 42), and 10 weeks after the fourth administration (at day 42)
| Intervention | percentage of CD8 cells (Median) | ||
|---|---|---|---|
| Change from baseline to 24 hours post infusion 1 | Change from baseline to 24 hours post infusion 4 | Change from baseline to 10 weeks post infusion 4 | |
| Cohort 4-Arm 4A (Romidepsin) | 0.1 | -2.5 | 0.9 |
| Cohort 4-Arm 4B (Placebo for Romidepsin) | -4.1 | -.6 | -0.8 |
"Baseline is defined as the value at hour 0, where hour 0 is right before the single administration of Romidepsin or placebo (at entry).~Change was calculated as the value at 48 hours, 7 days and 28 days after the single administration of Romidepsin or placebo (at entry) minus the value at baseline." (NCT01933594)
Timeframe: Hour 0 and 48 hours, 7 days and 28 days after the single administration of Romidepsin or placebo (at entry)
| Intervention | percentage of CD8 cells (Median) | ||
|---|---|---|---|
| Change from baseline to 48 hours post infusion | Change from baseline to 7 days post infusion | Change from baseline to 28 days post infusion | |
| Cohorts 1-3 (Placebo for Romidepsin) | 1.8 | -1.1 | -1.9 |
| Cohorts 1-3 (Romidepsin) | -0.1 | 0.3 | 0.9 |
Baseline is defined as the average of the pre-entry and entry values. Change was calculated as the value at 24 hours after each administration of Romidepsin or placebo (at entry, and days 14, 28 and 42) minus the value at baseline. (NCT01933594)
Timeframe: Pre-entry, entry, 24 hours after each administration of Romidepsin or placebo (at entry, and days 14, 28 and 42)
| Intervention | log10 copies/mL (Median) | |||
|---|---|---|---|---|
| Change from baseline to 24 hours post infusion 1 | Change from baseline to 24 hours post infusion 2 | Change from baseline to 24 hours post infusion 3 | Change from baseline to 24 hours post infusion 4 | |
| Cohort 4-Arm 4A (Romidepsin) | 0 | 0.03 | 0.3 | 0 |
| Cohort 4-Arm 4B (Placebo for Romidepsin) | -0.11 | 0.15 | 0.47 | 0.33 |
Baseline is defined as the average of the pre-entry and entry values. Change was calculated as the value at 6 hours, 12 hours, 7 days, 14 days and 28 days after administration of Romidepsin or placebo (at entry) minus the value at baseline. (NCT01933594)
Timeframe: Pre-entry, entry, 6 hours, 12 hours, 7 days, 14 days and 28 days after the single administration of Romidepsin or placebo (at entry)
| Intervention | log10 copies/mL (Median) | ||||
|---|---|---|---|---|---|
| Change from baseline to 6 hours post infusion | Change from baseline to 12 hours post infusion | Change from baseline to 7 days post infusion | Change from baseline to 14 days post infusion | Change from baseline to 28 days post infusion | |
| Cohorts 1-3 (Placebo for Romidepsin) | 0.14 | 0.27 | 0.27 | -0.13 | -0.08 |
| Cohorts 1-3 (Romidepsin) | -0.02 | 0 | 0 | 0 | 0 |
"Baseline is defined as the value at hour 0, where hour 0 is right before the single administration of Romidepsin or placebo (at entry).~Change was calculated as the value at 24 hours after the single administration of Romidepsin or placebo (at entry) minus the value at baseline." (NCT01933594)
Timeframe: Hour 0 and 24 hours after the single administration of Romidepsin or placebo (at entry)
| Intervention | percentage of CD4 cells (Median) | |
|---|---|---|
| Change in pNFKB+% on CD4 | Change in pS175% on CD4 | |
| Cohorts 1-3 (Placebo for Romidepsin) | 19.3 | 6 |
| Cohorts 1-3 (Romidepsin) | 20 | 18.1 |
"Baseline is defined as the value at hour 0, where hour 0 is right before the single administration of Romidepsin or placebo (at entry).~Change was calculated as the value at 24 hours after the single administration of Romidepsin or placebo (at entry) minus the value at baseline." (NCT01933594)
Timeframe: Hour 0 and 24 hours after the single administration of Romidepsin or placebo (at entry)
| Intervention | percentage of CD8 cells (Median) | |
|---|---|---|
| Change in pNFKB+% on CD8 | Change in pS175% on CD8 | |
| Cohorts 1-3 (Placebo for Romidepsin) | 3.8 | 25.3 |
| Cohorts 1-3 (Romidepsin) | 16.5 | 26.5 |
Baseline is defined as the average of the pre-entry and entry values. Change was calculated as the value at 24 hours after each administration of Romidepsin or placebo (at entry, and days 14, 28 and 42) and 72 hours after the second administration (at day 14) minus the value at baseline. (NCT01933594)
Timeframe: Pre-entry, entry, 24 hours after each administration of Romidepsin or placebo (at entry, and days 14, 28 and 42) and 72 hours after the second administration (at day 14)
| Intervention | percentage of CD4 cells (Median) | ||||
|---|---|---|---|---|---|
| Change from baseline to 24 hours post infusion 1 | Change from baseline to 24 hours post infusion 2 | Change from baseline to 72 hours post infusion 2 | Change from baseline to 24 hours post infusion 3 | Change from baseline to 24 hours post infusion 4 | |
| Cohort 4-Arm 4A (Romidepsin) | 5.04 | 8.78 | 6.39 | 5.78 | 9.63 |
| Cohort 4-Arm 4B (Placebo for Romidepsin) | 0.01 | 0 | 0 | 0 | 0 |
Baseline is defined as the average of the pre-entry and entry values. Change was calculated as the value at 24 hours after each administration of Romidepsin or placebo (at entry, and days 14, 28 and 42) and 72 hours after the second administration (at day 14) minus the value at baseline. (NCT01933594)
Timeframe: Pre-entry, entry, 24 hours after each administration of Romidepsin or placebo (at entry, and days 14, 28 and 42) and 72 hours after the second administration (at day 14)
| Intervention | percentage of CD4 cells (Median) | ||||
|---|---|---|---|---|---|
| Change from baseline to 24 hours post infusion 1 | Change from baseline to 24 hours post infusion 2 | Change from baseline to 72 hours post infusion 2 | Change from baseline to 24 hours post infusion 3 | Change from baseline to 24 hours post infusion 4 | |
| Cohort 4-Arm 4A (Romidepsin) | 9.93 | 17 | 11 | 14.85 | 16.52 |
| Cohort 4-Arm 4B (Placebo for Romidepsin) | -0.01 | -0.01 | -0.01 | 0 | 0.01 |
Baseline is defined as the average of the pre-entry and entry values. Change was calculated as the value at 24 hours after each administration of Romidepsin or placebo (at entry, and days 14, 28 and 42) and 72 hours after the second administration minus the value at baseline. (NCT01933594)
Timeframe: Pre-entry, 24 hours after each administration of Romidepsin or placebo (at entry, and days 14, 28 and 42) and 72 hours after the second administration (at day 14)
| Intervention | log10 (copies/10^6 PBMCs) (Median) | ||||
|---|---|---|---|---|---|
| Change from baseline to 24 hours post infusion 1 | Change from baseline to 24 hours post infusion 2 | Change from baseline to 72 hours post infusion 2 | Change from baseline to 24 hours post infusion 3 | Change from baseline to 24 hours post infusion 4 | |
| Cohort 4-Arm 4A (Romidepsin) | -0.06 | -0.13 | -0.13 | -0.06 | -0.14 |
| Cohort 4-Arm 4B (Placebo for Romidepsin) | -0.04 | -0.11 | -0.07 | -0.13 | -0.07 |
Baseline is defined as the pre-entry value. Change was calculated as the value at 24 hours and 14 days after administration of Romidepsin or placebo (at entry) minus the value at baseline. (NCT01933594)
Timeframe: Pre-entry, 24 hours and 14 days after the single administration of Romidepsin or placebo (at entry)
| Intervention | log10 (copies/10^6 resting CD4 cells) (Median) | |
|---|---|---|
| Change from baseline to 24 hours post infusion | Change from baseline to 14 days post infusion | |
| Cohorts 1-3 (Placebo for Romidepsin) | 0.05 | -0.05 |
| Cohorts 1-3 (Romidepsin) | -0.04 | -0.01 |
"PK concentration (ng/mL) for Romidepsin pre and post the third and fourth administrations of Romidepsin or placebo.~PK concentration (ng/mL) for co-administered antiretroviral drugs (Dolutegravir [DTG], or Raltegravir [RAL]) 24 hours after the third and fourth administrations of Romidepsin or placebo." (NCT01933594)
Timeframe: Pre, post and 24 hours after the third and fourth administrations of Romidepsin or placebo (at days 28 and 42)
| Intervention | ng/mL (Median) | |
|---|---|---|
| DTG PK concentration 24 hours post infusion 3 | DTG PK concentration 24 hours post infusion 4 | |
| Cohort 4-Arm 4B (Placebo for Romidepsin) | 913 | 833 |
"PK concentration (ng/mL) for Romidepsin pre and post the third and fourth administrations of Romidepsin or placebo.~PK concentration (ng/mL) for co-administered antiretroviral drugs (Dolutegravir [DTG], or Raltegravir [RAL]) 24 hours after the third and fourth administrations of Romidepsin or placebo." (NCT01933594)
Timeframe: Pre, post and 24 hours after the third and fourth administrations of Romidepsin or placebo (at days 28 and 42)
| Intervention | ng/mL (Median) | |||||||
|---|---|---|---|---|---|---|---|---|
| RMD PK concentration pre infusion 3 | RMD PK concentration post infusion 3 | RMD PK concentration pre infusion 4 | RMD PK concentration post infusion 4 | RAL PK concentration 24 hours post infusion 3 | RAL PK concentration 24 hours post infusion 4 | DTG PK concentration 24 hours post infusion 3 | DTG PK concentration 24 hours post infusion 4 | |
| Cohort 4-Arm 4A (Romidepsin) | 207 | 69 | NA | 134 | 906 | 567 | 2124 | 1568 |
"Hour 0 is right before the single administration of Romidepsin or placebo (at entry).~Hour 4 is at the completion of Romidepsin or placebo administration. Hours 6, 12 and 24 are 2, 8 and 20 hours after the completion of Romidepsin or placebo administration.~PK concentration (ng/mL) for Romidepsin at hours 0, 4, 6, 12 and 24. PK concentration (ng/mL) for co-administered antiretroviral drugs (Efavirenz [EFV], Dolutegravir [DTG], or Raltegravir [RAL]) at hours 0 and 24." (NCT01933594)
Timeframe: At hours 0, 4, 6, 12 and 24
| Intervention | ng/mL (Median) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| RMD PK concentration at Hour 0 | RMD PK concentration at Hour 4 | RMD PK concentration at Hour 6 | RMD PK concentration at Hour 12 | RMD PK concentration at Hour 24 | EFV PK concentration at Hour 0 | EFV PK concentration at Hour 24 | RAL PK concentration at Hour 0 | RAL PK concentration at Hour 24 | DTG PK concentration at Hour 0 | DTG PK concentration at Hour 24 | |
| Cohort 2-Arm 2A (Romidepsin) | NA | 75.2 | 2.7 | NA | NA | 2560 | 1870 | 910 | 398 | 4035 | 2190 |
"Hour 0 is right before the single administration of Romidepsin or placebo (at entry).~Hour 4 is at the completion of Romidepsin or placebo administration. Hours 6, 12 and 24 are 2, 8 and 20 hours after the completion of Romidepsin or placebo administration.~PK concentration (ng/mL) for Romidepsin at hours 0, 4, 6, 12 and 24. PK concentration (ng/mL) for co-administered antiretroviral drugs (Efavirenz [EFV], Dolutegravir [DTG], or Raltegravir [RAL]) at hours 0 and 24." (NCT01933594)
Timeframe: At hours 0, 4, 6, 12 and 24
| Intervention | ng/mL (Median) | |||
|---|---|---|---|---|
| EFV PK concentration at Hour 0 | EFV PK concentration at Hour 24 | RAL PK concentration at Hour 0 | RAL PK concentration at Hour 24 | |
| Cohorts 1-3 (Placebo for Romidepsin) | 2520 | 1600 | 401 | 142 |
"Hour 0 is right before the single administration of Romidepsin or placebo (at entry).~Hour 4 is at the completion of Romidepsin or placebo administration. Hours 6, 12 and 24 are 2, 8 and 20 hours after the completion of Romidepsin or placebo administration.~PK concentration (ng/mL) for Romidepsin at hours 0, 4, 6, 12 and 24. PK concentration (ng/mL) for co-administered antiretroviral drugs (Efavirenz [EFV], Dolutegravir [DTG], or Raltegravir [RAL]) at hours 0 and 24." (NCT01933594)
Timeframe: At hours 0, 4, 6, 12 and 24
| Intervention | ng/mL (Median) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| RMD PK concentration at Hour 0 | RMD PK concentration at Hour 4 | RMD PK concentration at Hour 6 | RMD PK concentration at Hour 12 | RMD PK concentration at Hour 24 | EFV PK concentration at Hour 0 | EFV PK concentration at Hour 24 | DTG PK concentration at Hour 0 | DTG PK concentration at Hour 24 | |
| Cohort 3-Arm 3A (Romidepsin) | NA | 89 | 2.6 | NA | NA | 2612 | 2886 | 2988 | 2399 |
"Hour 0 is right before the single administration of Romidepsin or placebo (at entry).~Hour 4 is at the completion of Romidepsin or placebo administration. Hours 6, 12 and 24 are 2, 8 and 20 hours after the completion of Romidepsin or placebo administration.~PK concentration (ng/mL) for Romidepsin at hours 0, 4, 6, 12 and 24. PK concentration (ng/mL) for co-administered antiretroviral drugs (Efavirenz [EFV], Dolutegravir [DTG], or Raltegravir [RAL]) at hours 0 and 24." (NCT01933594)
Timeframe: At hours 0, 4, 6, 12 and 24
| Intervention | ng/mL (Median) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| RMD PK concentration at Hour 0 | RMD PK concentration at Hour 4 | RMD PK concentration at Hour 6 | RMD PK concentration at Hour 12 | RMD PK concentration at Hour 24 | EFV PK concentration at Hour 0 | EFV PK concentration at Hour 24 | RAL PK concentration at Hour 0 | RAL PK concentration at Hour 24 | |
| Cohort 1-Arm 1A (Romidepsin) | NA | 12 | 3.2 | NA | NA | 2030 | 2105 | 777 | 1234 |
HIV-1 RNA levels at 7 days after each administration of Romidepsin or placebo (at entry, and days 14, 28 and 42) (NCT01933594)
Timeframe: 7 days after each administration of Romidepsin or placebo (at entry, and days 14, 28 and 42)
| Intervention | Participants (Count of Participants) | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| HIV-1 RNA level at day 7 post infusion 171941744 | HIV-1 RNA level at day 7 post infusion 171941745 | HIV-1 RNA level at day 7 post infusion 271941745 | HIV-1 RNA level at day 7 post infusion 271941744 | HIV-1 RNA level at day 7 post infusion 371941744 | HIV-1 RNA level at day 7 post infusion 371941745 | HIV-1 RNA level at day 7 post infusion 471941744 | HIV-1 RNA level at day 7 post infusion 471941745 | |||||||||
| 40 - 199 copies/mL | < 40 copies/mL | |||||||||||||||
| Cohort 4-Arm 4A (Romidepsin) | 13 | |||||||||||||||
| Cohort 4-Arm 4B (Placebo for Romidepsin) | 2 | |||||||||||||||
| Cohort 4-Arm 4B (Placebo for Romidepsin) | 0 | |||||||||||||||
| Cohort 4-Arm 4A (Romidepsin) | 8 | |||||||||||||||
| Cohort 4-Arm 4A (Romidepsin) | 0 | |||||||||||||||
| Cohort 4-Arm 4A (Romidepsin) | 11 | |||||||||||||||
| Cohort 4-Arm 4B (Placebo for Romidepsin) | 3 | |||||||||||||||
4 reviews available for valproic acid and HIV Infections
| Article | Year |
|---|---|
Alopecias due to drugs and other skin and systemic disorders.
Topics: Alopecia; Anticonvulsants; Antidepressive Agents; Antineoplastic Agents; Dermatologic Agents; Dermat | 2015 |
Alopecias due to drugs and other skin and systemic disorders.
Topics: Alopecia; Anticonvulsants; Antidepressive Agents; Antineoplastic Agents; Dermatologic Agents; Dermat | 2015 |
Structure-function studies for the panacea, valproic acid.
Topics: Animals; Anticonvulsants; Bipolar Disorder; Epilepsy; gamma-Aminobutyric Acid; Glycogen Synthase Kin | 2009 |
Structure-function studies for the panacea, valproic acid.
Topics: Animals; Anticonvulsants; Bipolar Disorder; Epilepsy; gamma-Aminobutyric Acid; Glycogen Synthase Kin | 2009 |
Role of psychiatric medications as adjunct therapy in the treatment of HIV associated neurocognitive disorders.
Topics: Antiretroviral Therapy, Highly Active; Brain; Citalopram; Cognition Disorders; HIV Infections; Human | 2008 |
Role of psychiatric medications as adjunct therapy in the treatment of HIV associated neurocognitive disorders.
Topics: Antiretroviral Therapy, Highly Active; Brain; Citalopram; Cognition Disorders; HIV Infections; Human | 2008 |
The use of valproic acid in HIV-positive patients.
Topics: Anticonvulsants; HIV Infections; Humans; Seizures; Valproic Acid | 1999 |
The use of valproic acid in HIV-positive patients.
Topics: Anticonvulsants; HIV Infections; Humans; Seizures; Valproic Acid | 1999 |
7 trials available for valproic acid and HIV Infections
| Article | Year |
|---|---|
The BAF complex inhibitor pyrimethamine reverses HIV-1 latency in people with HIV-1 on antiretroviral therapy.
Topics: CD4-Positive T-Lymphocytes; HIV Infections; HIV-1; Humans; Pyrimethamine; RNA; Valproic Acid; Virus | 2023 |
The BAF complex inhibitor pyrimethamine reverses HIV-1 latency in people with HIV-1 on antiretroviral therapy.
Topics: CD4-Positive T-Lymphocytes; HIV Infections; HIV-1; Humans; Pyrimethamine; RNA; Valproic Acid; Virus | 2023 |
The dolutegravir/valproic acid drug-drug interaction is primarily based on protein displacement.
Topics: Drug Interactions; Heterocyclic Compounds, 3-Ring; HIV Infections; Humans; Oxazines; Pharmaceutical | 2021 |
The dolutegravir/valproic acid drug-drug interaction is primarily based on protein displacement.
Topics: Drug Interactions; Heterocyclic Compounds, 3-Ring; HIV Infections; Humans; Oxazines; Pharmaceutical | 2021 |
Antiretroviral intensification and valproic acid lack sustained effect on residual HIV-1 viremia or resting CD4+ cell infection.
Topics: Antiretroviral Therapy, Highly Active; CD4-CD8 Ratio; CD4-Positive T-Lymphocytes; Drug Administratio | 2010 |
Antiretroviral intensification and valproic acid lack sustained effect on residual HIV-1 viremia or resting CD4+ cell infection.
Topics: Antiretroviral Therapy, Highly Active; CD4-CD8 Ratio; CD4-Positive T-Lymphocytes; Drug Administratio | 2010 |
Antiretroviral intensification and valproic acid lack sustained effect on residual HIV-1 viremia or resting CD4+ cell infection.
Topics: Antiretroviral Therapy, Highly Active; CD4-CD8 Ratio; CD4-Positive T-Lymphocytes; Drug Administratio | 2010 |
Antiretroviral intensification and valproic acid lack sustained effect on residual HIV-1 viremia or resting CD4+ cell infection.
Topics: Antiretroviral Therapy, Highly Active; CD4-CD8 Ratio; CD4-Positive T-Lymphocytes; Drug Administratio | 2010 |
Antiretroviral intensification and valproic acid lack sustained effect on residual HIV-1 viremia or resting CD4+ cell infection.
Topics: Antiretroviral Therapy, Highly Active; CD4-CD8 Ratio; CD4-Positive T-Lymphocytes; Drug Administratio | 2010 |
Antiretroviral intensification and valproic acid lack sustained effect on residual HIV-1 viremia or resting CD4+ cell infection.
Topics: Antiretroviral Therapy, Highly Active; CD4-CD8 Ratio; CD4-Positive T-Lymphocytes; Drug Administratio | 2010 |
Antiretroviral intensification and valproic acid lack sustained effect on residual HIV-1 viremia or resting CD4+ cell infection.
Topics: Antiretroviral Therapy, Highly Active; CD4-CD8 Ratio; CD4-Positive T-Lymphocytes; Drug Administratio | 2010 |
Antiretroviral intensification and valproic acid lack sustained effect on residual HIV-1 viremia or resting CD4+ cell infection.
Topics: Antiretroviral Therapy, Highly Active; CD4-CD8 Ratio; CD4-Positive T-Lymphocytes; Drug Administratio | 2010 |
Antiretroviral intensification and valproic acid lack sustained effect on residual HIV-1 viremia or resting CD4+ cell infection.
Topics: Antiretroviral Therapy, Highly Active; CD4-CD8 Ratio; CD4-Positive T-Lymphocytes; Drug Administratio | 2010 |
Antiretroviral intensification and valproic acid lack sustained effect on residual HIV-1 viremia or resting CD4+ cell infection.
Topics: Antiretroviral Therapy, Highly Active; CD4-CD8 Ratio; CD4-Positive T-Lymphocytes; Drug Administratio | 2010 |
Antiretroviral intensification and valproic acid lack sustained effect on residual HIV-1 viremia or resting CD4+ cell infection.
Topics: Antiretroviral Therapy, Highly Active; CD4-CD8 Ratio; CD4-Positive T-Lymphocytes; Drug Administratio | 2010 |
Antiretroviral intensification and valproic acid lack sustained effect on residual HIV-1 viremia or resting CD4+ cell infection.
Topics: Antiretroviral Therapy, Highly Active; CD4-CD8 Ratio; CD4-Positive T-Lymphocytes; Drug Administratio | 2010 |
Antiretroviral intensification and valproic acid lack sustained effect on residual HIV-1 viremia or resting CD4+ cell infection.
Topics: Antiretroviral Therapy, Highly Active; CD4-CD8 Ratio; CD4-Positive T-Lymphocytes; Drug Administratio | 2010 |
Antiretroviral intensification and valproic acid lack sustained effect on residual HIV-1 viremia or resting CD4+ cell infection.
Topics: Antiretroviral Therapy, Highly Active; CD4-CD8 Ratio; CD4-Positive T-Lymphocytes; Drug Administratio | 2010 |
Antiretroviral intensification and valproic acid lack sustained effect on residual HIV-1 viremia or resting CD4+ cell infection.
Topics: Antiretroviral Therapy, Highly Active; CD4-CD8 Ratio; CD4-Positive T-Lymphocytes; Drug Administratio | 2010 |
Antiretroviral intensification and valproic acid lack sustained effect on residual HIV-1 viremia or resting CD4+ cell infection.
Topics: Antiretroviral Therapy, Highly Active; CD4-CD8 Ratio; CD4-Positive T-Lymphocytes; Drug Administratio | 2010 |
Antiretroviral intensification and valproic acid lack sustained effect on residual HIV-1 viremia or resting CD4+ cell infection.
Topics: Antiretroviral Therapy, Highly Active; CD4-CD8 Ratio; CD4-Positive T-Lymphocytes; Drug Administratio | 2010 |
Antiretroviral intensification and valproic acid lack sustained effect on residual HIV-1 viremia or resting CD4+ cell infection.
Topics: Antiretroviral Therapy, Highly Active; CD4-CD8 Ratio; CD4-Positive T-Lymphocytes; Drug Administratio | 2010 |
Antiretroviral intensification and valproic acid lack sustained effect on residual HIV-1 viremia or resting CD4+ cell infection.
Topics: Antiretroviral Therapy, Highly Active; CD4-CD8 Ratio; CD4-Positive T-Lymphocytes; Drug Administratio | 2010 |
Antiretroviral intensification and valproic acid lack sustained effect on residual HIV-1 viremia or resting CD4+ cell infection.
Topics: Antiretroviral Therapy, Highly Active; CD4-CD8 Ratio; CD4-Positive T-Lymphocytes; Drug Administratio | 2010 |
Antiretroviral intensification and valproic acid lack sustained effect on residual HIV-1 viremia or resting CD4+ cell infection.
Topics: Antiretroviral Therapy, Highly Active; CD4-CD8 Ratio; CD4-Positive T-Lymphocytes; Drug Administratio | 2010 |
Antiretroviral intensification and valproic acid lack sustained effect on residual HIV-1 viremia or resting CD4+ cell infection.
Topics: Antiretroviral Therapy, Highly Active; CD4-CD8 Ratio; CD4-Positive T-Lymphocytes; Drug Administratio | 2010 |
Antiretroviral intensification and valproic acid lack sustained effect on residual HIV-1 viremia or resting CD4+ cell infection.
Topics: Antiretroviral Therapy, Highly Active; CD4-CD8 Ratio; CD4-Positive T-Lymphocytes; Drug Administratio | 2010 |
Antiretroviral intensification and valproic acid lack sustained effect on residual HIV-1 viremia or resting CD4+ cell infection.
Topics: Antiretroviral Therapy, Highly Active; CD4-CD8 Ratio; CD4-Positive T-Lymphocytes; Drug Administratio | 2010 |
Antiretroviral intensification and valproic acid lack sustained effect on residual HIV-1 viremia or resting CD4+ cell infection.
Topics: Antiretroviral Therapy, Highly Active; CD4-CD8 Ratio; CD4-Positive T-Lymphocytes; Drug Administratio | 2010 |
Antiretroviral intensification and valproic acid lack sustained effect on residual HIV-1 viremia or resting CD4+ cell infection.
Topics: Antiretroviral Therapy, Highly Active; CD4-CD8 Ratio; CD4-Positive T-Lymphocytes; Drug Administratio | 2010 |
Antiretroviral intensification and valproic acid lack sustained effect on residual HIV-1 viremia or resting CD4+ cell infection.
Topics: Antiretroviral Therapy, Highly Active; CD4-CD8 Ratio; CD4-Positive T-Lymphocytes; Drug Administratio | 2010 |
Antiretroviral intensification and valproic acid lack sustained effect on residual HIV-1 viremia or resting CD4+ cell infection.
Topics: Antiretroviral Therapy, Highly Active; CD4-CD8 Ratio; CD4-Positive T-Lymphocytes; Drug Administratio | 2010 |
Antiretroviral intensification and valproic acid lack sustained effect on residual HIV-1 viremia or resting CD4+ cell infection.
Topics: Antiretroviral Therapy, Highly Active; CD4-CD8 Ratio; CD4-Positive T-Lymphocytes; Drug Administratio | 2010 |
Antiretroviral intensification and valproic acid lack sustained effect on residual HIV-1 viremia or resting CD4+ cell infection.
Topics: Antiretroviral Therapy, Highly Active; CD4-CD8 Ratio; CD4-Positive T-Lymphocytes; Drug Administratio | 2010 |
Antiretroviral intensification and valproic acid lack sustained effect on residual HIV-1 viremia or resting CD4+ cell infection.
Topics: Antiretroviral Therapy, Highly Active; CD4-CD8 Ratio; CD4-Positive T-Lymphocytes; Drug Administratio | 2010 |
Antiretroviral intensification and valproic acid lack sustained effect on residual HIV-1 viremia or resting CD4+ cell infection.
Topics: Antiretroviral Therapy, Highly Active; CD4-CD8 Ratio; CD4-Positive T-Lymphocytes; Drug Administratio | 2010 |
Valproic acid in association with highly active antiretroviral therapy for reducing systemic HIV-1 reservoirs: results from a multicentre randomized clinical study.
Topics: Adult; Aged; Aged, 80 and over; Antiretroviral Therapy, Highly Active; CD4-Positive T-Lymphocytes; C | 2012 |
Valproic acid in association with highly active antiretroviral therapy for reducing systemic HIV-1 reservoirs: results from a multicentre randomized clinical study.
Topics: Adult; Aged; Aged, 80 and over; Antiretroviral Therapy, Highly Active; CD4-Positive T-Lymphocytes; C | 2012 |
Valproic acid adjunctive therapy for HIV-associated cognitive impairment: a first report.
Topics: Adult; AIDS Dementia Complex; Anti-Retroviral Agents; CD4 Lymphocyte Count; Double-Blind Method; Dru | 2006 |
Valproic acid adjunctive therapy for HIV-associated cognitive impairment: a first report.
Topics: Adult; AIDS Dementia Complex; Anti-Retroviral Agents; CD4 Lymphocyte Count; Double-Blind Method; Dru | 2006 |
Valproic acid is associated with cognitive decline in HIV-infected individuals: a clinical observational study.
Topics: Cognition; Cognition Disorders; Cohort Studies; Dose-Response Relationship, Drug; Female; HIV Infect | 2006 |
Valproic acid is associated with cognitive decline in HIV-infected individuals: a clinical observational study.
Topics: Cognition; Cognition Disorders; Cohort Studies; Dose-Response Relationship, Drug; Female; HIV Infect | 2006 |
Pharmacokinetic interaction between zidovudine and valproic acid in patients infected with human immunodeficiency virus.
Topics: Adult; Biological Availability; Drug Synergism; Half-Life; HIV Infections; Humans; Linear Models; Ma | 1994 |
Pharmacokinetic interaction between zidovudine and valproic acid in patients infected with human immunodeficiency virus.
Topics: Adult; Biological Availability; Drug Synergism; Half-Life; HIV Infections; Humans; Linear Models; Ma | 1994 |
33 other studies available for valproic acid and HIV Infections
| Article | Year |
|---|---|
Antiretroviral concentrations in the presence and absence of valproic acid.
Topics: Drug Interactions; Heterocyclic Compounds, 3-Ring; HIV Infections; HIV Integrase Inhibitors; Humans; | 2020 |
Antiretroviral concentrations in the presence and absence of valproic acid.
Topics: Drug Interactions; Heterocyclic Compounds, 3-Ring; HIV Infections; HIV Integrase Inhibitors; Humans; | 2020 |
Lower dolutegravir plasma concentrations in HIV-positive patients receiving valproic acid.
Topics: Anticonvulsants; Drug Interactions; Female; Heterocyclic Compounds, 3-Ring; HIV Infections; HIV Inte | 2018 |
Lower dolutegravir plasma concentrations in HIV-positive patients receiving valproic acid.
Topics: Anticonvulsants; Drug Interactions; Female; Heterocyclic Compounds, 3-Ring; HIV Infections; HIV Inte | 2018 |
Repurposing medications for use in treating HIV infection: A focus on valproic acid as a latency-reversing agent.
Topics: Anti-HIV Agents; CD4-Positive T-Lymphocytes; HIV Infections; HIV-1; Humans; Male; Middle Aged; Valpr | 2018 |
Repurposing medications for use in treating HIV infection: A focus on valproic acid as a latency-reversing agent.
Topics: Anti-HIV Agents; CD4-Positive T-Lymphocytes; HIV Infections; HIV-1; Humans; Male; Middle Aged; Valpr | 2018 |
Drug interactions are not always predictable: the curious case of valproic acid and dolutegravir and a possible explanation.
Topics: Adult; Anticonvulsants; Blood Chemical Analysis; Drug Interactions; Female; Heterocyclic Compounds, | 2019 |
Drug interactions are not always predictable: the curious case of valproic acid and dolutegravir and a possible explanation.
Topics: Adult; Anticonvulsants; Blood Chemical Analysis; Drug Interactions; Female; Heterocyclic Compounds, | 2019 |
Valproic acid inhibits the release of soluble CD40L induced by non-nucleoside reverse transcriptase inhibitors in human immunodeficiency virus infected individuals.
Topics: Alkynes; Benzoxazines; Blood Platelets; Blood-Brain Barrier; CD40 Ligand; Cyclopropanes; Enzyme Inhi | 2013 |
Valproic acid inhibits the release of soluble CD40L induced by non-nucleoside reverse transcriptase inhibitors in human immunodeficiency virus infected individuals.
Topics: Alkynes; Benzoxazines; Blood Platelets; Blood-Brain Barrier; CD40 Ligand; Cyclopropanes; Enzyme Inhi | 2013 |
Prolonged valproic acid treatment does not reduce the size of latent HIV reservoir.
Topics: Adult; Anticonvulsants; Antiretroviral Therapy, Highly Active; Case-Control Studies; CD4-Positive T- | 2008 |
Prolonged valproic acid treatment does not reduce the size of latent HIV reservoir.
Topics: Adult; Anticonvulsants; Antiretroviral Therapy, Highly Active; Case-Control Studies; CD4-Positive T- | 2008 |
Valproic acid without intensified antiviral therapy has limited impact on persistent HIV infection of resting CD4+ T cells.
Topics: Antiretroviral Therapy, Highly Active; CD4-CD8 Ratio; CD4-Positive T-Lymphocytes; Drug Therapy, Comb | 2008 |
Valproic acid without intensified antiviral therapy has limited impact on persistent HIV infection of resting CD4+ T cells.
Topics: Antiretroviral Therapy, Highly Active; CD4-CD8 Ratio; CD4-Positive T-Lymphocytes; Drug Therapy, Comb | 2008 |
Valproic acid without intensified antiviral therapy has limited impact on persistent HIV infection of resting CD4+ T cells.
Topics: Antiretroviral Therapy, Highly Active; CD4-CD8 Ratio; CD4-Positive T-Lymphocytes; Drug Therapy, Comb | 2008 |
Valproic acid without intensified antiviral therapy has limited impact on persistent HIV infection of resting CD4+ T cells.
Topics: Antiretroviral Therapy, Highly Active; CD4-CD8 Ratio; CD4-Positive T-Lymphocytes; Drug Therapy, Comb | 2008 |
Valproic acid without intensified antiviral therapy has limited impact on persistent HIV infection of resting CD4+ T cells.
Topics: Antiretroviral Therapy, Highly Active; CD4-CD8 Ratio; CD4-Positive T-Lymphocytes; Drug Therapy, Comb | 2008 |
Valproic acid without intensified antiviral therapy has limited impact on persistent HIV infection of resting CD4+ T cells.
Topics: Antiretroviral Therapy, Highly Active; CD4-CD8 Ratio; CD4-Positive T-Lymphocytes; Drug Therapy, Comb | 2008 |
Valproic acid without intensified antiviral therapy has limited impact on persistent HIV infection of resting CD4+ T cells.
Topics: Antiretroviral Therapy, Highly Active; CD4-CD8 Ratio; CD4-Positive T-Lymphocytes; Drug Therapy, Comb | 2008 |
Valproic acid without intensified antiviral therapy has limited impact on persistent HIV infection of resting CD4+ T cells.
Topics: Antiretroviral Therapy, Highly Active; CD4-CD8 Ratio; CD4-Positive T-Lymphocytes; Drug Therapy, Comb | 2008 |
Valproic acid without intensified antiviral therapy has limited impact on persistent HIV infection of resting CD4+ T cells.
Topics: Antiretroviral Therapy, Highly Active; CD4-CD8 Ratio; CD4-Positive T-Lymphocytes; Drug Therapy, Comb | 2008 |
Valproic acid without intensified antiviral therapy has limited impact on persistent HIV infection of resting CD4+ T cells.
Topics: Antiretroviral Therapy, Highly Active; CD4-CD8 Ratio; CD4-Positive T-Lymphocytes; Drug Therapy, Comb | 2008 |
Valproic acid without intensified antiviral therapy has limited impact on persistent HIV infection of resting CD4+ T cells.
Topics: Antiretroviral Therapy, Highly Active; CD4-CD8 Ratio; CD4-Positive T-Lymphocytes; Drug Therapy, Comb | 2008 |
Valproic acid without intensified antiviral therapy has limited impact on persistent HIV infection of resting CD4+ T cells.
Topics: Antiretroviral Therapy, Highly Active; CD4-CD8 Ratio; CD4-Positive T-Lymphocytes; Drug Therapy, Comb | 2008 |
Valproic acid without intensified antiviral therapy has limited impact on persistent HIV infection of resting CD4+ T cells.
Topics: Antiretroviral Therapy, Highly Active; CD4-CD8 Ratio; CD4-Positive T-Lymphocytes; Drug Therapy, Comb | 2008 |
Valproic acid without intensified antiviral therapy has limited impact on persistent HIV infection of resting CD4+ T cells.
Topics: Antiretroviral Therapy, Highly Active; CD4-CD8 Ratio; CD4-Positive T-Lymphocytes; Drug Therapy, Comb | 2008 |
Valproic acid without intensified antiviral therapy has limited impact on persistent HIV infection of resting CD4+ T cells.
Topics: Antiretroviral Therapy, Highly Active; CD4-CD8 Ratio; CD4-Positive T-Lymphocytes; Drug Therapy, Comb | 2008 |
Valproic acid without intensified antiviral therapy has limited impact on persistent HIV infection of resting CD4+ T cells.
Topics: Antiretroviral Therapy, Highly Active; CD4-CD8 Ratio; CD4-Positive T-Lymphocytes; Drug Therapy, Comb | 2008 |
Valproic acid without intensified antiviral therapy has limited impact on persistent HIV infection of resting CD4+ T cells.
Topics: Antiretroviral Therapy, Highly Active; CD4-CD8 Ratio; CD4-Positive T-Lymphocytes; Drug Therapy, Comb | 2008 |
Valproic acid without intensified antiviral therapy has limited impact on persistent HIV infection of resting CD4+ T cells.
Topics: Antiretroviral Therapy, Highly Active; CD4-CD8 Ratio; CD4-Positive T-Lymphocytes; Drug Therapy, Comb | 2008 |
Valproic acid without intensified antiviral therapy has limited impact on persistent HIV infection of resting CD4+ T cells.
Topics: Antiretroviral Therapy, Highly Active; CD4-CD8 Ratio; CD4-Positive T-Lymphocytes; Drug Therapy, Comb | 2008 |
Valproic acid without intensified antiviral therapy has limited impact on persistent HIV infection of resting CD4+ T cells.
Topics: Antiretroviral Therapy, Highly Active; CD4-CD8 Ratio; CD4-Positive T-Lymphocytes; Drug Therapy, Comb | 2008 |
Valproic acid without intensified antiviral therapy has limited impact on persistent HIV infection of resting CD4+ T cells.
Topics: Antiretroviral Therapy, Highly Active; CD4-CD8 Ratio; CD4-Positive T-Lymphocytes; Drug Therapy, Comb | 2008 |
Valproic acid without intensified antiviral therapy has limited impact on persistent HIV infection of resting CD4+ T cells.
Topics: Antiretroviral Therapy, Highly Active; CD4-CD8 Ratio; CD4-Positive T-Lymphocytes; Drug Therapy, Comb | 2008 |
Valproic acid without intensified antiviral therapy has limited impact on persistent HIV infection of resting CD4+ T cells.
Topics: Antiretroviral Therapy, Highly Active; CD4-CD8 Ratio; CD4-Positive T-Lymphocytes; Drug Therapy, Comb | 2008 |
Valproic acid without intensified antiviral therapy has limited impact on persistent HIV infection of resting CD4+ T cells.
Topics: Antiretroviral Therapy, Highly Active; CD4-CD8 Ratio; CD4-Positive T-Lymphocytes; Drug Therapy, Comb | 2008 |
Valproic acid without intensified antiviral therapy has limited impact on persistent HIV infection of resting CD4+ T cells.
Topics: Antiretroviral Therapy, Highly Active; CD4-CD8 Ratio; CD4-Positive T-Lymphocytes; Drug Therapy, Comb | 2008 |
Valproic acid without intensified antiviral therapy has limited impact on persistent HIV infection of resting CD4+ T cells.
Topics: Antiretroviral Therapy, Highly Active; CD4-CD8 Ratio; CD4-Positive T-Lymphocytes; Drug Therapy, Comb | 2008 |
Valproic acid without intensified antiviral therapy has limited impact on persistent HIV infection of resting CD4+ T cells.
Topics: Antiretroviral Therapy, Highly Active; CD4-CD8 Ratio; CD4-Positive T-Lymphocytes; Drug Therapy, Comb | 2008 |
Valproic acid without intensified antiviral therapy has limited impact on persistent HIV infection of resting CD4+ T cells.
Topics: Antiretroviral Therapy, Highly Active; CD4-CD8 Ratio; CD4-Positive T-Lymphocytes; Drug Therapy, Comb | 2008 |
Valproic acid without intensified antiviral therapy has limited impact on persistent HIV infection of resting CD4+ T cells.
Topics: Antiretroviral Therapy, Highly Active; CD4-CD8 Ratio; CD4-Positive T-Lymphocytes; Drug Therapy, Comb | 2008 |
Valproic acid without intensified antiviral therapy has limited impact on persistent HIV infection of resting CD4+ T cells.
Topics: Antiretroviral Therapy, Highly Active; CD4-CD8 Ratio; CD4-Positive T-Lymphocytes; Drug Therapy, Comb | 2008 |
Valproic acid without intensified antiviral therapy has limited impact on persistent HIV infection of resting CD4+ T cells.
Topics: Antiretroviral Therapy, Highly Active; CD4-CD8 Ratio; CD4-Positive T-Lymphocytes; Drug Therapy, Comb | 2008 |
Valproic acid without intensified antiviral therapy has limited impact on persistent HIV infection of resting CD4+ T cells.
Topics: Antiretroviral Therapy, Highly Active; CD4-CD8 Ratio; CD4-Positive T-Lymphocytes; Drug Therapy, Comb | 2008 |
Effects of minocycline and valproic acid coadministration on atazanavir plasma concentrations in human immunodeficiency virus-infected adults receiving atazanavir-ritonavir.
Topics: Adult; Anticonvulsants; Atazanavir Sulfate; Cognition Disorders; Drug Interactions; Drug Therapy, Co | 2008 |
Effects of minocycline and valproic acid coadministration on atazanavir plasma concentrations in human immunodeficiency virus-infected adults receiving atazanavir-ritonavir.
Topics: Adult; Anticonvulsants; Atazanavir Sulfate; Cognition Disorders; Drug Interactions; Drug Therapy, Co | 2008 |
Perspectives on interactions between antiepileptic drugs (AEDs) and antimicrobial agents.
Topics: Aged; Anti-Infective Agents; Anticonvulsants; Brain Abscess; Drug Interactions; Epilepsy; Female; He | 2008 |
Perspectives on interactions between antiepileptic drugs (AEDs) and antimicrobial agents.
Topics: Aged; Anti-Infective Agents; Anticonvulsants; Brain Abscess; Drug Interactions; Epilepsy; Female; He | 2008 |
Probing past a seizure.
Topics: Anticonvulsants; Cryptococcus neoformans; Epilepsy, Tonic-Clonic; HIV Infections; Humans; Male; Meni | 2010 |
Probing past a seizure.
Topics: Anticonvulsants; Cryptococcus neoformans; Epilepsy, Tonic-Clonic; HIV Infections; Humans; Male; Meni | 2010 |
Clinical outcomes and immune benefits of anti-epileptic drug therapy in HIV/AIDS.
Topics: Acquired Immunodeficiency Syndrome; Adult; Anticonvulsants; Calcium Channel Blockers; CD4 Antigens; | 2010 |
Clinical outcomes and immune benefits of anti-epileptic drug therapy in HIV/AIDS.
Topics: Acquired Immunodeficiency Syndrome; Adult; Anticonvulsants; Calcium Channel Blockers; CD4 Antigens; | 2010 |
Sodium valproate and highly active antiretroviral therapy in HIV positive patients who develop new onset seizures.
Topics: Adult; Antiretroviral Therapy, Highly Active; Child; Drug Therapy, Combination; Female; HIV Infectio | 2011 |
Sodium valproate and highly active antiretroviral therapy in HIV positive patients who develop new onset seizures.
Topics: Adult; Antiretroviral Therapy, Highly Active; Child; Drug Therapy, Combination; Female; HIV Infectio | 2011 |
Secretion of MIP-1β and MIP-1α by CD8(+) T-lymphocytes correlates with HIV-1 inhibition independent of coreceptor usage.
Topics: Acetylation; CD8-Positive T-Lymphocytes; Chemokine CCL3; Chemokine CCL4; Chemokine CXCL10; Down-Regu | 2011 |
Secretion of MIP-1β and MIP-1α by CD8(+) T-lymphocytes correlates with HIV-1 inhibition independent of coreceptor usage.
Topics: Acetylation; CD8-Positive T-Lymphocytes; Chemokine CCL3; Chemokine CCL4; Chemokine CXCL10; Down-Regu | 2011 |
Antiplatelet activity of valproic acid contributes to decreased soluble CD40 ligand production in HIV type 1-infected individuals.
Topics: AIDS Dementia Complex; Animals; Blood Platelets; CD40 Ligand; Down-Regulation; Female; Glycogen Synt | 2011 |
Antiplatelet activity of valproic acid contributes to decreased soluble CD40 ligand production in HIV type 1-infected individuals.
Topics: AIDS Dementia Complex; Animals; Blood Platelets; CD40 Ligand; Down-Regulation; Female; Glycogen Synt | 2011 |
Latent HIV in primary T lymphocytes is unresponsive to histone deacetylase inhibitors.
Topics: CD4-Positive T-Lymphocytes; Cells, Cultured; Coculture Techniques; Histone Deacetylase Inhibitors; H | 2011 |
Latent HIV in primary T lymphocytes is unresponsive to histone deacetylase inhibitors.
Topics: CD4-Positive T-Lymphocytes; Cells, Cultured; Coculture Techniques; Histone Deacetylase Inhibitors; H | 2011 |
Effect of histone deacetylase inhibitors on HIV production in latently infected, resting CD4(+) T cells from infected individuals receiving effective antiretroviral therapy.
Topics: CD4-Positive T-Lymphocytes; DNA, Viral; Flow Cytometry; Histone Deacetylase Inhibitors; HIV Infectio | 2012 |
Effect of histone deacetylase inhibitors on HIV production in latently infected, resting CD4(+) T cells from infected individuals receiving effective antiretroviral therapy.
Topics: CD4-Positive T-Lymphocytes; DNA, Viral; Flow Cytometry; Histone Deacetylase Inhibitors; HIV Infectio | 2012 |
Prevalence of seizures in children infected with human immunodeficiency virus.
Topics: Anticonvulsants; Carbamazepine; Child; Child, Preschool; Female; HIV Infections; Humans; Male; Pheno | 2013 |
Prevalence of seizures in children infected with human immunodeficiency virus.
Topics: Anticonvulsants; Carbamazepine; Child; Child, Preschool; Female; HIV Infections; Humans; Male; Pheno | 2013 |
Severe anemia secondary to a probable drug interaction between zidovudine and valproic acid.
Topics: Anemia; Anti-HIV Agents; Antiretroviral Therapy, Highly Active; Dideoxynucleosides; Drug Interaction | 2004 |
Severe anemia secondary to a probable drug interaction between zidovudine and valproic acid.
Topics: Anemia; Anti-HIV Agents; Antiretroviral Therapy, Highly Active; Dideoxynucleosides; Drug Interaction | 2004 |
Coaxing HIV-1 from resting CD4 T cells: histone deacetylase inhibition allows latent viral expression.
Topics: Acetylation; CD4-Positive T-Lymphocytes; Disease Reservoirs; Enzyme Inhibitors; Histone Deacetylase | 2004 |
Coaxing HIV-1 from resting CD4 T cells: histone deacetylase inhibition allows latent viral expression.
Topics: Acetylation; CD4-Positive T-Lymphocytes; Disease Reservoirs; Enzyme Inhibitors; Histone Deacetylase | 2004 |
Coaxing HIV-1 from resting CD4 T cells: histone deacetylase inhibition allows latent viral expression.
Topics: Acetylation; CD4-Positive T-Lymphocytes; Disease Reservoirs; Enzyme Inhibitors; Histone Deacetylase | 2004 |
Coaxing HIV-1 from resting CD4 T cells: histone deacetylase inhibition allows latent viral expression.
Topics: Acetylation; CD4-Positive T-Lymphocytes; Disease Reservoirs; Enzyme Inhibitors; Histone Deacetylase | 2004 |
Coaxing HIV-1 from resting CD4 T cells: histone deacetylase inhibition allows latent viral expression.
Topics: Acetylation; CD4-Positive T-Lymphocytes; Disease Reservoirs; Enzyme Inhibitors; Histone Deacetylase | 2004 |
Coaxing HIV-1 from resting CD4 T cells: histone deacetylase inhibition allows latent viral expression.
Topics: Acetylation; CD4-Positive T-Lymphocytes; Disease Reservoirs; Enzyme Inhibitors; Histone Deacetylase | 2004 |
Coaxing HIV-1 from resting CD4 T cells: histone deacetylase inhibition allows latent viral expression.
Topics: Acetylation; CD4-Positive T-Lymphocytes; Disease Reservoirs; Enzyme Inhibitors; Histone Deacetylase | 2004 |
Coaxing HIV-1 from resting CD4 T cells: histone deacetylase inhibition allows latent viral expression.
Topics: Acetylation; CD4-Positive T-Lymphocytes; Disease Reservoirs; Enzyme Inhibitors; Histone Deacetylase | 2004 |
Effects of valproic acid coadministration on plasma efavirenz and lopinavir concentrations in human immunodeficiency virus-infected adults.
Topics: Adult; Alkynes; Anti-HIV Agents; Anticonvulsants; Area Under Curve; Benzoxazines; Cognition Disorder | 2004 |
Effects of valproic acid coadministration on plasma efavirenz and lopinavir concentrations in human immunodeficiency virus-infected adults.
Topics: Adult; Alkynes; Anti-HIV Agents; Anticonvulsants; Area Under Curve; Benzoxazines; Cognition Disorder | 2004 |
HIV/AIDS. Report of novel treatment aimed at latent HIV raises the 'c word'.
Topics: Anti-HIV Agents; Antiretroviral Therapy, Highly Active; CD4-Positive T-Lymphocytes; Enfuvirtide; Enz | 2005 |
HIV/AIDS. Report of novel treatment aimed at latent HIV raises the 'c word'.
Topics: Anti-HIV Agents; Antiretroviral Therapy, Highly Active; CD4-Positive T-Lymphocytes; Enfuvirtide; Enz | 2005 |
Possible interaction between lopinavir/ritonavir and valproic Acid exacerbates bipolar disorder.
Topics: Adult; Antiretroviral Therapy, Highly Active; Bipolar Disorder; Dose-Response Relationship, Drug; Dr | 2006 |
Possible interaction between lopinavir/ritonavir and valproic Acid exacerbates bipolar disorder.
Topics: Adult; Antiretroviral Therapy, Highly Active; Bipolar Disorder; Dose-Response Relationship, Drug; Dr | 2006 |
New research finds possible treatment for latent HIV. Valproic acid used to deplete HIV.
Topics: Antiretroviral Therapy, Highly Active; CD4-Positive T-Lymphocytes; Drug Therapy, Combination; HIV In | 2005 |
New research finds possible treatment for latent HIV. Valproic acid used to deplete HIV.
Topics: Antiretroviral Therapy, Highly Active; CD4-Positive T-Lymphocytes; Drug Therapy, Combination; HIV In | 2005 |
Targeting HIV reservoirs with valproic acid.
Topics: CD4-Positive T-Lymphocytes; Disease Reservoirs; Enzyme-Linked Immunosorbent Assay; HIV Infections; H | 2005 |
Targeting HIV reservoirs with valproic acid.
Topics: CD4-Positive T-Lymphocytes; Disease Reservoirs; Enzyme-Linked Immunosorbent Assay; HIV Infections; H | 2005 |
No change to HIV-1 latency with valproate therapy.
Topics: Anti-Retroviral Agents; Anticonvulsants; HIV Infections; HIV-1; Humans; Male; Middle Aged; Valproic | 2006 |
No change to HIV-1 latency with valproate therapy.
Topics: Anti-Retroviral Agents; Anticonvulsants; HIV Infections; HIV-1; Humans; Male; Middle Aged; Valproic | 2006 |
Reduced valproate plasma levels possible after introduction of efavirenz in a bipolar patient.
Topics: Adult; Alkynes; Anti-HIV Agents; Anticonvulsants; Benzoxazines; Bipolar Disorder; Cyclopropanes; Dos | 2006 |
Reduced valproate plasma levels possible after introduction of efavirenz in a bipolar patient.
Topics: Adult; Alkynes; Anti-HIV Agents; Anticonvulsants; Benzoxazines; Bipolar Disorder; Cyclopropanes; Dos | 2006 |
Valproic acid does not affect markers of human immunodeficiency virus disease progression.
Topics: Adult; Anticonvulsants; Biomarkers; CD4 Lymphocyte Count; CD4-Positive T-Lymphocytes; Disease Progre | 2006 |
Valproic acid does not affect markers of human immunodeficiency virus disease progression.
Topics: Adult; Anticonvulsants; Biomarkers; CD4 Lymphocyte Count; CD4-Positive T-Lymphocytes; Disease Progre | 2006 |
No cure yet for HIV-1, but therapeutic research presses on.
Topics: CD4-Positive T-Lymphocytes; Disease Reservoirs; HIV Infections; HIV-1; Humans; Research; Valproic Ac | 2007 |
No cure yet for HIV-1, but therapeutic research presses on.
Topics: CD4-Positive T-Lymphocytes; Disease Reservoirs; HIV Infections; HIV-1; Humans; Research; Valproic Ac | 2007 |
Stability of the latent reservoir for HIV-1 in patients receiving valproic acid.
Topics: Adult; Antiretroviral Therapy, Highly Active; CD4-Positive T-Lymphocytes; Disease Reservoirs; HIV In | 2007 |
Stability of the latent reservoir for HIV-1 in patients receiving valproic acid.
Topics: Adult; Antiretroviral Therapy, Highly Active; CD4-Positive T-Lymphocytes; Disease Reservoirs; HIV In | 2007 |
Stability of the latent reservoir for HIV-1 in patients receiving valproic acid.
Topics: Adult; Antiretroviral Therapy, Highly Active; CD4-Positive T-Lymphocytes; Disease Reservoirs; HIV In | 2007 |
Stability of the latent reservoir for HIV-1 in patients receiving valproic acid.
Topics: Adult; Antiretroviral Therapy, Highly Active; CD4-Positive T-Lymphocytes; Disease Reservoirs; HIV In | 2007 |
Stability of the latent reservoir for HIV-1 in patients receiving valproic acid.
Topics: Adult; Antiretroviral Therapy, Highly Active; CD4-Positive T-Lymphocytes; Disease Reservoirs; HIV In | 2007 |
Stability of the latent reservoir for HIV-1 in patients receiving valproic acid.
Topics: Adult; Antiretroviral Therapy, Highly Active; CD4-Positive T-Lymphocytes; Disease Reservoirs; HIV In | 2007 |
Stability of the latent reservoir for HIV-1 in patients receiving valproic acid.
Topics: Adult; Antiretroviral Therapy, Highly Active; CD4-Positive T-Lymphocytes; Disease Reservoirs; HIV In | 2007 |
Stability of the latent reservoir for HIV-1 in patients receiving valproic acid.
Topics: Adult; Antiretroviral Therapy, Highly Active; CD4-Positive T-Lymphocytes; Disease Reservoirs; HIV In | 2007 |
The effect of divalproex sodium on HIV replication in vivo.
Topics: Adult; CD4 Lymphocyte Count; Enzyme Inhibitors; Female; HIV; HIV Infections; Humans; Male; Middle Ag | 2007 |
The effect of divalproex sodium on HIV replication in vivo.
Topics: Adult; CD4 Lymphocyte Count; Enzyme Inhibitors; Female; HIV; HIV Infections; Humans; Male; Middle Ag | 2007 |
Elevated free phenytoin and free valproic acid concentrations in sera of patients infected with human immunodeficiency virus.
Topics: Anticonvulsants; Chemistry, Pharmaceutical; HIV Infections; Humans; Phenytoin; Polypharmacy; Seizure | 1998 |
Elevated free phenytoin and free valproic acid concentrations in sera of patients infected with human immunodeficiency virus.
Topics: Anticonvulsants; Chemistry, Pharmaceutical; HIV Infections; Humans; Phenytoin; Polypharmacy; Seizure | 1998 |
Does valproate pose a threat to human immunodeficiency virus-infected patients?
Topics: HIV Infections; Humans; Risk Factors; Valproic Acid | 1999 |
Does valproate pose a threat to human immunodeficiency virus-infected patients?
Topics: HIV Infections; Humans; Risk Factors; Valproic Acid | 1999 |
Multiple mitochondrial DNA deletions and lactic acidosis in an HIV-infected patient under antiretroviral therapy.
Topics: Acidosis, Lactic; Anti-HIV Agents; Cell Line; DNA, Mitochondrial; Drug Therapy, Combination; Enzyme | 2001 |
Multiple mitochondrial DNA deletions and lactic acidosis in an HIV-infected patient under antiretroviral therapy.
Topics: Acidosis, Lactic; Anti-HIV Agents; Cell Line; DNA, Mitochondrial; Drug Therapy, Combination; Enzyme | 2001 |