Clinical trials: LAM
Lymphangioleiomyomatosis (LAM)
COLA: A Pilot Clinical Trial of COX-2 Inhibition in LAM and TSC
The investigators will perform a two-center phase I trial of celecoxib (COX-2 inhibitor) administered at 200mg by mouth daily for 6 months. Up to 12 adult women with LAM will be recruited (between 4-8 at each site).
- Trial name
- COLA (NCT02484664)
- Testing
- Celecoxib
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Brigham and Women's Hospital
Infection, Human Immunodeficiency Virus
A Phase IV, Open Label, 4-period Cross-over Study to Investigate a Drug Interaction Between Lamivudine and Sorbitol Oral Solutions in Healthy Volunteers
Lamivudine (3TC) is a nucleoside analogue indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and children.
- Trial name
- NCT02634073
- Testing
- Lamivudine, Sorbitol
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Hepatitis B, Chronic
A Study of Pegylated Interferon Alfa-2a and Lamivudine in Patients With HBeAg-Negative Chronic Hepatitis B Virus (HBV)
This study will compare the efficacy and safety of 2 different durations of treatment with pegylated interferon (PEG-IFN) alfa-2a in participants with Hepatitis B e Antigen (HBeAg)-negative chronic hepatitis B virus (HBV).
- Trial name
- NCT01095835
- Testing
- Pegylated interferon (PEG-IFN) alfa-2a, 180 mcg, Pegylated interferon (PEG-IFN) alfa-2a, 135 mcg, Lamivudine (LAM)
- Where
- 22 sites in Italy
- Volunteers
- 131 people
- Sponsor
- Hoffmann-La Roche
HIV Infections
Description of Real World Antiviral Effectiveness and Sustainability of the 2-Drug Regimen Dolutegravir + Lamivudine in Untreated and Pre-treated Patients in Routine Clinical Care in Germany
This is a prospective, non-interventional, multi-center study, in participants with clinical indication of Human Immunodeficiency Virus (HIV)-1 infection.
- Trial name
- URBAN (NCT03754803)
- Testing
- HIV symptom distress module (SDM) questionnaire, HIV treatment satisfaction questionnaire (TSQ)
- Where
- 18 sites in Germany
- Volunteers
- 376 people
- Sponsor
- ViiV Healthcare
HIV-1 Infection
Safety and Efficacy of Switching From Dolutegravir and ABC/3TC or ABC/DTG/3TC to B/F/TAF in HIV-1 Infected Adults Who Are Virologically Suppressed
The primary objective of this study is to evaluate the efficacy of switching from a regimen of dolutegravir (DTG) and abacavir/lamivudine (ABC/3TC) or a fixed dose combination (FDC) of abacavir/dolutegravir/lamivudine…
- Trial name
- NCT02603120
- Testing
- ABC/DTG/3TC, B/F/TAF
- Where
- 94 sites in United States, Australia and 8 more
- Volunteers
- 567 people
- Sponsor
- Gilead Sciences
Lymphangioleiomyomatosis
Discovery of Sirolimus Sensitive Biomarkers in Blood
Background: Lymphangioleiomyomatosis (LAM) is a rare, progressive disease. It usually affects women in the prime of their lives. It typically results in lung destruction.
- Trial name
- NCT03304678
- Testing
- Sirolimus 2mg
- Where
- United States
- Volunteers
- 33 people
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
Hepatitis B, Chronic
Entecavir Plus Adefovir Combination Therapy Versus Entecavir Monotherapy vs Therapy With Adefovir Plus Lamivudine for Chronic Hepatitis B Infected Subjects With Lamivudine-resistant Virus
The purpose of this study is to evaluate the effectiveness of entecavir plus adefovir combination therapy versus entecavir monotherapy or therapy with adefovir plus lamivudine
- Trial name
- DEFINE (NCT00410202)
- Testing
- Entecavir, Tenofovir, Adefovir
- Where
- 67 sites in United States, Australia and 16 more
- Volunteers
- 629 people
- Sponsor
- Bristol-Myers Squibb
Infection, Human Immunodeficiency Virus
A Phase IIIb Study of the Safety, Efficacy, and Tolerability of Switching to a Fixed-dose Combination of Abacavir/Dolutegravir/ Lamivudine From Current Antiretroviral Regimen
This study is a 48-week, Phase IIIb, randomly assigned, open-label, active-controlled, multicenter, parallel group, non-inferiority study.
- Trial name
- NCT02105987
- Testing
- ABC/DTG/3TC FDC, Ongoing cART regimen
- Where
- 103 sites in United States, Canada and 1 more
- Volunteers
- 555 people
- Sponsor
- ViiV Healthcare
Infection, Human Immunodeficiency Virus
Dose-finding Study of GSK2248761 in Antiretroviral Therapy-Naive Subjects (SIGNET)
This 96 week, Phase 2b study in 150 HIV-1 infected antiretroviral (ART) naive adult subjects consists of a dose-ranging evaluation of GSK2248761 at blinded doses of 100 mg and 200 mg once daily with a control arm of open-label…
- Trial name
- SIGNET (NCT01231555)
- Testing
- GSK2248761 100 mg once daily, GSK2248761 200 mg once daily, Efavirenz 600 mg once daily
- Where
- 12 sites in France, Germany and 1 more
- Volunteers
- 23 people
- Sponsor
- ViiV Healthcare
Infection, Human Immunodeficiency Virus
A Dose Ranging Trial of GSK1349572 and 2 NRTI in HIV-1 Infected, Therapy Naive Subjects
This Phase IIb study in HIV-infected antiretroviral naive subjects will select an optimal once daily dose of GSK1349572 from a range of doses for future evaluation.
- Trial name
- ING112276 (NCT00951015)
- Testing
- GSK1349572, efavirenz
- Where
- 35 sites in United States, France and 4 more
- Volunteers
- 208 people
- Sponsor
- ViiV Healthcare
Lymphangioleiomyomatosis
Efficacy and Safety of Sirolimus in LAM
Lymphangioleiomyomatosis (LAM) is a rare lung disease of women that is caused by genetic mutations. It results in the uncontrolled growth of an unusual type of smooth muscle cell in the lung.
- Trial name
- MILES (NCT00414648)
- Testing
- Sirolimus
- Where
- 13 sites in United States, Canada and 1 more
- Volunteers
- 89 people
- Sponsor
- University of Cincinnati
HIV Infections
Efavirenz or Atazanavir/Ritonavir Given With Emtricitabine/Tenofovir Disoproxil Fumarate or Abacavir/Lamivudine in HIV Infected Treatment-Naive Adults
Currently, the preferred anti-HIV regimens used in the United States consist of two nucleoside reverse transcriptase inhibitors (NRTIs) and the nonnucleoside reverse transcriptase inhibitor (NNRTI) efavirenz (EFV).
- Trial name
- NCT00118898
- Testing
- Abacavir/Lamivudine, Atazanavir, Efavirenz
- Where
- 52 sites in United States, Puerto Rico
- Volunteers
- 1,864 people
- Sponsor
- Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Tumor, Tumor, Solid
Phase 2 Basket Trial of Nab-sirolimus in Patients With Malignant Solid Tumors With Pathogenic Alterations in TSC1/TSC2 Genes (PRECISION 1)
A Phase 2 multi-center open-label basket trial of nab-sirolimus for adult and adolescent patients with malignant solid tumors harboring pathogenic inactivating alterations in TSC1 or TSC2 genes
- Conditions
- Tumor, Tumor, Solid, Metastasis, Metastatic Cancer
- Trial name
- NCT05103358
- Testing
- nab-sirolimus
- Where
- 166 sites in United States, Puerto Rico and 1 more
- Volunteers
- 128 people
- Sponsor
- Aadi Bioscience, Inc.
Infection, Human Immunodeficiency Virus, HIV Infections
ING200336, Pharmacokinetic and Safety Study in Pregnant Women With Human Immuno Virus Infection
In this study, the dolutegravir/abacavir/lamivudine (DTG/ABC/3TC) fixed dose combination (FDC) tablet is being made available to women who become pregnant while participating in study ING117172.
- Conditions
- Infection, Human Immunodeficiency Virus, HIV Infections, Arthralgia
- Trial name
- NCT02075593
- Testing
- DTG 50 mg /ABC 600 mg /3TC 300 mg FDC tablets
- Where
- 3 sites in Russia, Spain
- Volunteers
- 4 people
- Sponsor
- ViiV Healthcare