Clinical trials: LAM
Seizure in Participants With Tuberous Sclerosis Complex, Seizure in Participants With Dravet Syndrome
Assessment of Adjunctive Cannabidiol Oral Solution (GWP42003-P) in Children With Tuberous Sclerosis Complex (TSC), Dravet Syndrome (DS), or Lennox-Gastaut Syndrome (LGS) Who Experience Inadequately-controlled Seizures
This study will be conducted to evaluate the safety, pharmacokinetics (PK), and efficacy of adjunctive GWP42003-P in participants < 2 years of age with tuberous sclerosis complex (TSC), Lennox-Gastaut syndrome (LGS), or Dravet…
- Conditions
- Seizure in Participants With Tuberous Sclerosis Complex, Seizure in Participants With Dravet Syndrome, Seizure in Participants With Lennox-Gastaut Syndrome
- Trial name
- NCT04485104
- Testing
- GWP42003-P
- Where
- 11 sites in United States, Italy and 1 more
- Volunteers
- 3 people
- Sponsor
- Jazz Pharmaceuticals
Hiv
Defining the Potency of DTG/3TC for Suppressed HIV Patients in Real-life: the DUALING Study
This study aims to determine real-life clinical efficacy of virally suppressed patienst switching to DTG/3TC compared to DTG triple drug cART controls
- Trial name
- DUALING (NCT04707326)
- Testing
- Dolutegravir / Lamivudine Pill
- Where
- 9 sites in Netherlands
- Volunteers
- 2,040 people
- Sponsor
- Erasmus Medical Center
HIV, Acute HIV Infection
Safety and Efficacy of Fixed Dose Combination Dolutegravir/Abacavir/Lamivudine FDC Initiated During Acute HIV Infection
This is a multicenter, single arm, 96-week open-label study of the safety and virologic efficacy of fixed dose combination Dolutegravir/Lamivudine/Abacavir (DTG/3TC/ABC FDC) initiated during acute HIV infection (AHI).
- Trial name
- PHI-05 (NCT02384395)
- Testing
- Dolutegravir 50 mg, Lamivudine 300 mg, Abacavir 600 mg
- Where
- 2 sites in United States
- Volunteers
- 40 people
- Sponsor
- University of North Carolina, Chapel Hill
HIV-1 Infection
Safety and Efficacy of Switching From Regimens of ABC/3TC + a 3rd Agent to E/C/F/TAF Fixed-Dose Combination (FDC) in Virologically-Suppressed HIV 1 Infected Adults
The primary objective of this study is to evaluate the efficacy of switching to elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) relative to continuing on a baseline regimen…
- Trial name
- NCT02605954
- Testing
- E/C/F/TAF, ABC/3TC, Third Antiretroviral Agent
- Where
- 49 sites in United States, France and 4 more
- Volunteers
- 275 people
- Sponsor
- Gilead Sciences
Hiv
The Effect on Lipid Profile of Switching to Delstrigo in HIV Positive Patients
This is an open label, randomised, two-arm switch study over 48 weeks in which virally suppressed participants on a stable combined ART regimen will be randomised (1:1) to an immediate switch to 3TC/TDF/DOR (immediate switch arm…
- Trial name
- META-D (NCT05289986)
- Testing
- DELSTRIGO 100Mg-300Mg-300Mg Tablet
- Where
- 2 sites in United Kingdom
- Volunteers
- 19 people
- Sponsor
- Chelsea and Westminster NHS Foundation Trust
Chronic Hepatitis B
A Phase IIIb Study to Compare Entecavir Plus Tenofovir vs. Adefovir Added to Continuing Lamivudine Therapy in Adult Patients With Lamivudine-Resistant Hepatitis B Infection
The purpose of this clinical research study is to find out whether a combination of entecavir (ETV) plus tenofovir (TNF) works better against Hepatitis B virus than adefovir (ADV) added to continuing lamivudine (LVD) therapy in…
- Trial name
- NCT00605384
- Testing
- Entecavir + Tenofovir, Adefovir + continuing Lamivudine
- Where
- 29 sites in United States, Belgium and 4 more
- Volunteers
- 4 people
- Sponsor
- Bristol-Myers Squibb
HBV (Hepatitis B Virus), Hepatitis B
Lamivudine and Adefovir to Treat Chronic Hepatitis B
This study will evaluate the safety and effectiveness of lamivudine plus adefovir versus adefovir alone to treat chronic hepatitis B infection.
- Conditions
- HBV (Hepatitis B Virus), Hepatitis B, Hepatitis
- Trial name
- NCT00023309
- Testing
- Lamivudine and adefovir, Adefovir alone
- Where
- United States
- Volunteers
- 41 people
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Infection, Human Immunodeficiency Virus I, HIV Infection
Induction/Simplification With Atazanavir + Ritonavir + Abacavir/Lamivudine Fixed-Dose Combination In HIV-1 Infection
This study was designed to test the efficacy, safety, tolerability and durability of the antiviral response between atazanavir (ATV) + ritonavir (/r) + abacavir/lamivudine(ABC/3TC) Fixed dose combination (FDC) each administered…
- Trial name
- NCT00440947
- Testing
- Abacavir (ABC)/lamivudine (3TC) + atazanavir (ATV) + ritonavir (/r), Abacavir (ABC)/lamivudine (3TC) + atazanavir (ATV)
- Where
- 72 sites in United States, Canada and 1 more
- Volunteers
- 515 people
- Sponsor
- ViiV Healthcare
HIV Infections
A Food-effect Study of the Pediatric Dispersible Tablet Formulations of TRIUMEQ® and DOVATO® in Healthy Adult Participants
This study will assess the effect of food on the pharmacokinetics (PK) of pediatric formulations of TRIUMEQ (dolutegravir [DTG] 5 milligrams [mg]/abacavir [ABC] 60 mg/lamivudine [3TC] 30 mg) dispersible tablets and DOVATO (DTG 5…
- Trial name
- NCT04827134
- Testing
- TRIUMEQ, DOVATO
- Where
- United States
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
HIV
Open-Label Study Comparing Efficacy and Safety of ATV/RTV+3TC With ATV/RTV+TDF/FTC in HIV-Infected, Treatment Naïve Subjects, Followed by Treatment With ATV/RTV+3TC
The primary objective of this study in antiretroviral (ARV)-naïve Human immunodeficiency virus 1 (HIV-1) ribonucleic acid infected subjects is to compare the response rate at Week 48 of a daily regimen of Atazanavir (ATV)/…
- Trial name
- NCT01620944
- Testing
- Atazanavir, Ritonavir, Lamivudine
- Volunteers
- 3 people
- Sponsor
- Bristol-Myers Squibb
Nonmalignant Neoplasm, Tuberous Sclerosis
RAPAMYCIN FOR KIDNEY ANGIOMYOLIPOMAS
This research study is evaluating a drug called rapamycin as a possible treatment for the lumps (or tumors) that form in the kidneys, called angiomyolipomas, in people who have either TSC or LAM.
- Conditions
- Nonmalignant Neoplasm, Tuberous Sclerosis, Lymphangioleimyomatosis, Kidney Angiomyolipoma
- Trial name
- NCT00126672
- Testing
- Rapamycin
- Where
- 7 sites in United States
- Volunteers
- 36 people
- Sponsor
- Dana-Farber Cancer Institute
Lymphangioleiomyomatosis, Tuberous Sclerosis Complex
Safety of Simvastatin in LAM and TSC
The purpose of this research study is to see if simvastatin can be taken safely in patients with either LAM or TSC, who are already being treated with everolimus or sirolimus.
- Trial name
- SOS (NCT02061397)
- Testing
- Simvastatin, Sirolimus Oral Product, Everolimus Oral Product
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- University of Pennsylvania
HIV Infections
Switch Study to Evaluate Dolutegravir Plus Lamivudine in Virologically Suppressed Human Immunodeficiency Virus Type 1 Positive Adults (TANGO)
The aim of the study is to establish if human immunodeficiency virus type 1 (HIV-1) infected adult participants with current virologic suppression on a >=3-drug tenofovir alafenamide (TAF) based regimen (TBR) remain suppressed…
- Trial name
- NCT03446573
- Testing
- DTG + 3TC, TAF based regimen (TBR)
- Where
- 133 sites in United States, Australia and 8 more
- Volunteers
- 743 people
- Sponsor
- ViiV Healthcare
HIV Infections
Regimen Switch to Dolutegravir/Lamivudine Fixed Dose Combination From Current Antiretroviral Regimen in HIV-1 Infected and Virologically Suppressed Adults (SALSA)
The aim of this study is to determine if virologically suppressed Human Immunodeficiency Virus (HIV) Type 1 infected adults on a current antiretroviral regimen (CAR) (including 2 nucleoside reverse transcriptase inhibitors…
- Trial name
- NCT04021290
- Testing
- DTG/3TC FDC, CAR
- Where
- 119 sites in United States, Argentina and 15 more
- Volunteers
- 493 people
- Sponsor
- ViiV Healthcare
Infection, Human Immunodeficiency Virus
A Study of the Pharmacokinetics and Antiviral Activity of Dolutegravir in the Central Nervous System in HIV-1 Infected ART-naive Subjects
ING116070 is a Phase IIIb single-arm, open-label, multicenter study. The study will be conducted in approximately 14 HIV-1 infected antiretroviral therapy (ART)-naïve subjects.
- Trial name
- NCT01499199
- Testing
- Dolutegravir
- Where
- 3 sites in United States
- Volunteers
- 13 people
- Sponsor
- ViiV Healthcare
Lymphangioleiomyomatosis, Lymphangiomyomas
Treatment With Octreotide in Patients With Lymphangioleiomyomatosis
Lymphangioleiomyomatosis (LAM), a disease primarily of women of child-bearing age, is characterized by cystic lung disease and abdominal tumors (e.g., angiomyolipomas).
- Conditions
- Lymphangioleiomyomatosis, Lymphangiomyomas, Pleural Effusions, Ascites
- Trial name
- NCT00005906
- Testing
- Octreotide
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
HIV Infections
Cyclosporine A in Combination With Abacavir Sulfate, Lamivudine, and Zidovudine and Lopinavir/Ritonavir in HIV
Cyclosporine A (CsA) is a common long-term treatment used to inhibit the immune response in transplant patients who receive donor organs. CsA may also help people with HIV.
- Trial name
- NCT00084149
- Testing
- Abacavir sulfate, Lamivudine, and Zidovudine, Lopinavir/Ritonavir
- Where
- 4 sites in United States
- Volunteers
- 54 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Infection, Human Immunodeficiency Virus
A Simplification Study of Unboosted Reyataz With Epzicom (ASSURE)
This study is designed to compare the efficacy and safety of simplifying therapy from a regimen of atazanavir (ATV) + ritonavir (RTV) + tenofovir/emtricitabine (TDF/FTC) to a regimen of ATV + abacavir sulfate/lamivudine (ABC/3TC)…
- Trial name
- ASSURE (NCT01102972)
- Testing
- Reyataz + Norvir + Truvada, Reyataz + Epzicom
- Where
- 46 sites in United States, Puerto Rico
- Volunteers
- 297 people
- Sponsor
- ViiV Healthcare
HIV Infection
Safety and Efficacy Study of Switching From Epzicom to Truvada
This protocol describes a prospective, randomized, open-label, multicenter study to evaluate the safety and efficacy of switching from fixed dose abacavir (ABC)/lamivudine (3TC) to fixed dose emtricitabine (FTC)/tenofovir…
- Trial name
- SWIFT (NCT00724711)
- Testing
- emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF), abacavir (ABC)/lamivudine (3TC)
- Where
- 80 sites in United States, Canada and 1 more
- Volunteers
- 312 people
- Sponsor
- Gilead Sciences
HIV Infections
Tenofovir Disoproxil Fumarate/Emtricitabine/Efavirenz Versus Combivir/Efavirenz in Antiretroviral-Naive HIV-1 Infected Subjects
The purpose of Study GS-01-934 was to assess the efficacy and safety of two simplified antiretroviral treatment (ART) regimens in ART-naive, human immunodeficiency virus, type 1 (HIV-1) infected participants.
- Trial name
- NCT00112047
- Testing
- Emtricitabine (FTC), Tenofovir Disoproxil Fumarate (TDF), Efavirenz (EFV)
- Where
- 5 sites in United States
- Volunteers
- 517 people
- Sponsor
- Gilead Sciences