Studies
New Drug Development

HIV-NAT150

Study ID: HIV-NAT150
An open-label trial with TMC278 25 mg q.d. in combination with a background regimen containing 2 nucleoside/nucleotide reverse transcriptase inhibitors in HIV-1 infected subjects, who participated in TMC278 clinical trials. The purpose of the study is to provide continued access to TMC278 in HIV-1 infected patients who were randomized and treated with TMC278 in the Phase IIb or Phase III trials.
Status: Ongoing. Closed to recruitment. Patients are followed and monitored.
Target/Enrolled: 750 global/13 HIV-NAT

HIV-NAT160

Study ID: HIV-NAT160
Study Providing Continued Access to Treatment With Darunavir (DRV)/Ritonavir (Rtv) for Adults Coming From Any of the Three Ongoing Tibotec-Sponsored Studies With DRV. The primary objective of this trial is to continue the provision of DRV/rtv to adult patients who have completed treatment with DRV/rtv in the clinical trials TMC114-C211, TMC114-C214, or TMC114-TiDP31-C229, sponsored by Tibotec Pharmaceuticals, who continue to benefit from the use of DRV/rtv, and who live in a country where DRV is not commercially available, is not reimbursed, or cannot be accessed through another source (eg, access program, government program).
Status: Open late 2015

HIV-NAT182

Study ID: HIV-NAT182
A Phase 2/3, Open-Label Study of the Pharmacokinetics, Safety, and Antiviral Activity of the Elvitegravir/ Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate Single Tablet Regimen (STR) in HIV-1 Infected Antiretroviral Treatment-Naive Adolescents. This study is to evaluate the steady-state pharmacokinetics (PK) and confirm the dose of the elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (EVG/COBI/FTC/TDF) single tablet regimen (STR) in HIV-1 infected, antiretroviral (ARV) treatment-naive adolescents. Safety, tolerability, and efficacy will also be evaluated through Week 48.
Status: Ongoing
Target/Enrolled: 5/3

HIV-NAT187

Study ID: HIV-NAT187
A phase 3, randomized, double-blind study to evaluate the safety and efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide versus elvitegravir/cobicistat/emtricitabine/tnofovir disoproxil fumarate in HIV-1 positive, antiretroviral treatment-naïve adults. Randomized, Double-Blind, multicenter, active-controlled study to evaluate the Safety and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Versus Elvitegravir/Cobicistat/Emtricitabine/ Tenofovir Disoproxil Fumarate in achieving HIV-1 RNA < 50 copies/mL at Week 48 as defined by the FDA snapshot analysis in HIV-1 infected subjects.
Status: Ongoing. Closed to recruitment. Patients are followed and monitored.
Target/Enrolled: 840 global/42 HIV-NAT

HIV-NAT190

Study ID: HIV-NAT190
A Phase 2/3, Open-Label Study of the Pharmacokinetics, Safety, and Antiviral Activity of the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Single Tablet Regimen (STR) in HIV-1 Infected Antiretroviral Treatment-Naive Adolescents. This is an open-label, multicenter, two-part, single-arm study of the pharmacokinetics, safety, tolerability, and antiviral activity of the single tablet regimen (STR) elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) in HIV 1 infected, ARV treatment naive adolescents determined by the achievement of HIV-1 RNA < 50 copies/mL Weeks 24 and 48 as defined by the FDA snapshot analysis.
Status: Ongoing. Closed to recruitment. Patients are followed and monitored.
Target/Enrolled: 6/4

HIV-NAT191

Study ID: HIV-NAT191
A phase 3, open-label study to evaluate switching from a TDF-Containing Combination Regimen to a TAF-Containing Combination Single Tablet Regimen (STR) in Virologically-Suppressed, HIV-1 Positive Subjects. Randomized, open-label, multicenter, active-controlled study to evaluate the safety and efficacy of virologically suppressed subjects who switched from a FTC/TDF regimen to a tenofovir alafenamide (TAF)-containing regimen in achieving HIV-1 RNA < 50 copies/mL at Week 48 as defined by the FDA snapshot analysis in HIV-1 infected subjects.
Status: Ongoing. Closed to recruitment. Patients are followed and monitored.
Target/Enrolled: 1500 global/9 HIV-NAT

HIV-NAT193

Study ID: HIV-NAT193
A phase 3 open-label safety study of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide single-tablet regimen in HIV-1 positive patients with mild to moderate renal impairment. Open-label, multicenter, multi-cohort study to assess the safety, tolerability, and efficacy of a STR of E/C/F/TAF in HIV-positive, adult subjects with mild to moderate renal impairment.
Status: Ongoing. Closed to recruitment. Patients are followed and monitored.
Target/Enrolled: 298 global/14 HIV-NAT

HIV-NAT197

Study ID: HIV-NAT197
A phase IIIb, randomized, open-label study of the safety and efficacy of dolutegravir/abacavir/lamivudine once daily compared to atazanavir and ritonavir plus tenofovir/emtricitabine once daily in HIV-1 infected antiretroviral therapy naïve women. This study is designed to demonstrate the non-inferior antiviral activity of DTG/ABC/3TC fixed dose combination (FDC) once daily (OD) compared to atazanavir plus ritonavir (ATV+RTV) and tenofovir disoproxil fumarate/emtricitabine fixed dose combination (TDF/FTC FDC) OD in HIV-1 infected, ART-naïve women over 48 weeks. This study will also characterize the safety and tolerability of DTG/ABC/3TC FDC compared to ATV+RTV+TDF/FTC FDC.
Status: Ongoing. Closed to recruitment. Patients are followed and monitored.
Target/Enrolled: 730 global/11 HIV-NAT

HIV-NAT198

Study ID: HIV-NAT198
A Phase2/3 Multicenter, Open-label, Multicohort, Two-Part Study Evaluating the Pharmacokinetics (PK), Safety, and Antiviral Activity of Elvitegravir (EVG) Administered with a Background Regimen (BR) Containing a Ritonavir-boosted Protease Inhibitor (PI/r) in HIV-1 Infected, Antiretroviral Treatment-experienced Pediatric Subjects. This is an open-label, multicenter, multicohort, two-part study to confirm the dose and evaluate the safety and tolerability of ritonavir-boosted elvitegravir (EVG/r) in HIV-1 infected, treatment-experienced subjects aged 4 weeks to less than 18 years of age. The dose of EVG will be determined by intensive pharmacokinetic sampling at Day 10. The safety and antiviral activity of EVG will also be evaluated.
Status: Ongoing. Closed to recruitment. Patients are followed and monitored.
Target/Enrolled: 10/4

HIV-NAT208

Study ID: HIV-NAT208
A Phase 2/3, Multicenter, Open-label, Multicohort, Two-Part Study Evaluating Pharmacokinetics (PK), Safety, and Efficacy of Cobicistat-boosted Atazanavir (ATV/co) or Cobicistat-boosted Darunavir (DRV/co), Administered With Background Regimen (BR) in HIV-1 Infected, Treatment-Experienced, Virologically Suppressed Pediatric Subjects. This study will evaluate the steady-state pharmacokinetics (PK) and confirm the dose of cobicistat-boosted atazanavir (ATV/co) or cobicistat-boosted darunavir (DRV/co) in HIV-1 infected antiretroviral treatment-experienced pediatric participants between the ages of 3 months to < 18 years of age. It will also evaluate the safety, tolerability, and efficacy of ATV/co or DRV/co each co-administered with a background regimen (BR) through 48 weeks and during long-term treatment (total of 5 years).
Status: Ongoing. Closed to recruitment. Patients are followed and monitored.
Target/Enrolled: 10/3

HIV-NAT214

Study ID: HIV-NAT214
A Phase IIIb, randomized, open-label study of the safety and efficacy of dolutegravir or efavirenz each administered with two NRTIs in HIV-1-infected antiretroviral therapy-naïve adults starting treatment for rifampicin-sensitive tuberculosis. This is a Phase III b, randomized, open-label study describing the efficacy and safety of DTG and EFV-containing ART regimens in HIV/TB co-infected patients. This study is designed to assess the antiviral activity of DTG or efavirenz (EFV) ART-containing regimens through 48 weeks.
Status: Open Dec 2014
Target/Enrolled: 125 global/11 HIV-NAT

HIV-NAT215

Study ID: HIV-NAT215
Efficacy of Tenofovir Alafenamide Versus Placebo Added to a Failing Regimen Followed by Treatment With Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Plus Atazanavir in HIV-1 Positive, Antiretroviral Treatment-Experienced Adults. This is a phase 3, two part study to evaluate the efficacy of Tenofovir Alafenamide versus placebo added to a failing regimen followed by treatment with Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide plus Atazanavir in HIV-1 positive, antiretroviral treatment-experienced adults
Status: Opened May 2014. Study was premature terminated but enrolled patients are still actively followed
Target/Enrolled: 100 global/4 HIV-NAT

HIV-NAT216

Study ID: HIV-NAT216
Unable to disclose due to contractual agreement. Safety and Efficacy study conducted in adults
Status: Open late 2015

HIV-NAT218

Study ID: HIV-NAT218
A Phase 3b, Randomized, Open-label Study of the Antiviral Activity and Safety of Dolutegravir Compared to Lopinavir/Ritonavir Both Administered With Dual Nucleoside Reverse Transcriptase Inhibitor Therapy in HIV-1 Infected Adult Subjects With Treatment Failure on First Line Therapy. This study is conducted to demonstrate non-inferior antiviral activity at 48 weeks of a dolutegravir (DTG) containing regimen compared to a WHO-recommended standard of care regimen for second line treatment, LPV/RTV + two NRTIs, in HIV-1 infected patients failing first line therapy.
Status: Opened Aug 2014. Ongoing. Recruiting
Target/Enrolled: 612 global/11 HIV-NAT

HIV-NAT228

Study ID: HIV-NAT228
A Phase III Multicenter, Double-Blind, Randomized, Active Comparator-Controlled Clinical Trial to Evaluate the Safety and Efficacy of MK-1439A Once-Daily Versus ATRIPLA Once-Daily in Treatment-Naïve HIV-1 Infected Subjects. This study will compare the antiretroviral activity of MK-1439A, a single-tablet, once-daily (q.d.) fixed-dose combination (FDC) containing MK-1439 100 mg + lamivudine 300 mg + tenofovir disoproxil fumarate 300 mg, with ATRIPLA™, a single-tablet FDC containing efavirenz 600 mg + emtricitabine 200 mg + tenofovir disoproxil fumarate 300 mg, in treatment-naive participants infected with HIV
Status: Opened late 2015. Patients are followed and monitored.
Target/Enrolled: 680/19

HIV-NAT230

Study ID: HIV-NAT230
A Phase 2b Randomized, Active-Controlled, Double-Blind Trial to Investigate Safety, Efficacy, and Dose-response of BMS-955176, Given on a Backbone of Tenofovir/Emtricitabine, in Treatment-Naive HIV-1 Infected Adults. This study will find at least one dose of BMS-955176 that will be safe, effective and tolerable for HIV-1 infected treatment naive adults.
Status: Thailand sites were closed in May 2016 because subtype AE clade are not included in the study’s inclusion criteria
Target/Enrolled: 200/0

HIV-NAT231

Study ID: HIV-NAT231
A Phase 2b Randomized, Active-Controlled, Staged, Open-label Trial to Investigate Safety and Efficacy of BMS-955176 in Combination With Dolutegravir and Atazanavir (With or Without Ritonavir) in Treatment-Experienced HIV-1 Infected Adults. This study will evaluate whether the combination of BMS-955176 with atazanavir (ATV) [with or without ritonavir (RTV)] and dolutegravir (DTG) is efficacious, safe, and well-tolerated in HIV-1 infected treatment experienced adults.
Status: IRB submission and drug importation
Target/Enrolled: 200/0

HIV-NAT144

Study ID: HIV-NAT144
A phase IIb randomized, controlled, partially blinded clinical trial to investigate the safety, efficacy and dose-response of BMS-986001 in treatment –naïve HIV-1 infected subjects, followed by an open-label period on the recommended dose. Double Blind through Week 24. Partially Blind (to subjects, caregivers, Investigators) through Week 48.
Status: Closed 2014
Target/Enrolled: 25/21

Booster

Study ID: HIV-NAT138
A phase 3, randomized, double-blind study to evaluate the safety and efficacy of GF-9350-boosted Atazanavir versus ritonavir-boosted Atazanavir each administered with emtricitabine/tenofovir disoproxil fumarate in HIV-1 infected, antiretroviral treatment-naïve adults. This is a multicenter phase 3, randomized, double-blind, active-controlled study to evaluate the safety and efficacy of a regimen containing GS-9350-boosted atazanavir (ATV/GS-9350) versus ritonavir-boosted atazanavir (ATV/r) each administered with emtricitabine/tenofovir disoproxil fumarate (Truvada®, FTC/TDF) in HIV-1 infected, antiretroviral treatment-naïve adult subjects.
Status: Ongoing. Closed to recruitment. Patients are followed and monitored.
Target/Enrolled: 700 global/14 HIV-NAT

Continued Access to Etravirine (ETR) in Treatment Experienced HIV-1 Infected Children and Adolescents

Study ID: HIV-NAT142
The primary objective is to continue the provision of etravirine (ETR) for patients who previously received ETR in a clinical pediatric trial sponsored by or in collaboration with Tibotec, and who continue to benefit from the use of ETR, in countries where ETR is not commercially available for pediatric use, is not reimbursed, and cannot be accessed through another source (e.g. access program or government program), or where the patient is not eligible for ongoing trials/programs with ETR.
Status: Ongoing. Closed to recruitment. Patients are followed and monitored
Target/Enrolled: 6/6

Maraviroc in kids

Study ID: HIV-NAT156
An open-label, multicentre, multiple-dose pharmacokinetic, safety and efficacy trial of maraviroc in combination with optimized background therapy for the treatment of antiretroviral-experienced CCR-5 tropic HIV-1 infected children 2-<18. The study will evaluate the efficacy and safety of maraviroc in HIV-infected children.
Status: Opened on Feb 3, 2011. Ongoing. Closed to recruitment. Patients are followed and monitored.
Target/Enrolled: 10/1

PAINT

Study ID: HIV-NAT099
A Phase II, Open Label, Single Arm Trial to Evaluate the Pharmacokinetics,Safety, Tolerability, and Antiviral Activity of TMC278 in Antiretroviral Naive HIV-1 Infected Adolescents Aged 12 to < 18 Years. This is a Phase II, open-label (all people involved know the identity of the assigned drug) and single arm study. The purpose of this study is to evaluate the pharmacokinetics, safety and effectiveness of TMC278 25 mg once daily in combination with an investigator-selected background regimen containing 2 nucleoside reverse transcriptase inhibitors (NRTIs)
Status: Ongoing. Closed to recruitment. Patients are followed and monitored.
Target/Enrolled: 8/1

PRINCE 1

Study ID: HIV-NAT143
A Prospective Single Arm, Open-label, International, Multicenter Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Atazanavir (ATV) Powder Boosted with Ritonavir (RTV) Liquid with an Optimized NRTI Background Therapy, in HIV Infected Pediatric Patients Greater Than or Equal to 3 Months to Less Than 6 Years; Pediatric Atazanavir International Clinical Evaluation: the PRINCE I study. This study will evaluate the pharmacokinetic and efficacy data of atazanavir/r in HIV-infected children.
Status: Closed 2016
Target/Enrolled: 2/1

RAL OD vs RAL BID in ARV naïve

Study ID: HIV-NAT210
A Phase III Multicenter, Double-blind, Randomized, Active Comparator-Controlled Clinical Trial to Evaluate the Safety and Efficacy of Reformulated Raltegravir 1200 mg Once Daily Versus Raltegravir 400 mg Twice Daily, Each in Combination with TRUVADATM, in Treatment-Naïve HIV-1 Infected Subjects. This study will evaluate the safety and efficacy of reformulated raltegravir (MK-0518) 1200 mg once daily in combination with TRUVADA™ versus raltegravir 400 mg twice daily in combination with TRUVADA™ in HIV-1 infected, treatment-naive participants. The primary hypothesis being tested is that reformulated raltegravir 1200 mg once-daily is non-inferior to raltegravir 400 mg twice-daily, each in combination therapy with TRUVADA™, as assessed by the proportion of participants achieving HIV-1 ribonucleic acid (RNA) <40 copies/mL at Week 48.
Status: Recruiting
Target/Enrolled: 750 gobal/19 HIV-NAT

SALIF

Study ID: HIV-NAT204
A Phase 3b, Randomized, Open-label Clinical Study to Demonstrate Non-inferiority in Virologic Response Rates of HIV-1 RNA Suppression <400 Copies/mL of TDF/FTC/RPV Versus TDF/FTC/EFV in First-line Antiretroviral NNRTI-based Suppressed Patients. This randomized study will show that the efficacy of tenofovir disoproxil fumarate/emtricitabine/rilpivirine (TDF/FTC/RPV) is equivalent to the standard treatment TDF/FTC/efavirenz (TDF/FTC/EFV) in patients with plasma human immunodeficiency virus-type 1 (HIV-1) ribonucleic acid (RNA) levels less than 400 copies per mL after 48 weeks.
Status: Will close in Dec 2015
Target/Enrolled: 32/31

WAVES

Study ID: HIV-NAT195
A randomized, double-blind phase 3B study to evaluate the safety and efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate versus ritonavir-boosted atazanavir plus emtricitabine/tenofovir disoproxil fumarate in HIV 1 infected, antiretroviral treatment-naïve women. Randomized, double-blinded, multicenter, active-controlled study to evaluate the safety and efficacy of a regimen containing elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (EVG/COBI/FTC/TDF) administered as a single tablet regimen (STR) versus ritonavir-boosted atazanavir (ATV/r) plus emtricitabine/tenofovir disoproxil fumarate (Truvada® or FTC/TDF) in HIV 1 infected, antiretroviral treatment-naïve adult women.
Status: Ongoing. Closed to recruitment. Patients are followed and monitored.
Target/Enrolled: 510 global/8 HIV-NAT
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