Clinical trials: LAM
Infection, Human Immunodeficiency Virus I, HIV Infection
KIVEXA Vs TRUVADA, Both Administered With Efavirenz, In ART-Naive Subjects
Recently, the fixed-dose combinations (FDC) KIVEXA™ (abacavir/lamivudine) and TRUVADA (tenofovir disoproxil fumarate/emtricitabine) have facilitated the usage of once-daily regimens.
- Trial name
- ASSERT (NCT00549198)
- Testing
- Abacavir/lamivudine and efavirenz, Tenofovir/Emtricitabine and efavirenz
- Where
- 68 sites in Austria, Belgium and 11 more
- Volunteers
- 392 people
- Sponsor
- GlaxoSmithKline
HIV-1 Infection
Switch Study to Evaluate F/TAF in HIV-1 Infected Adults Who Are Virologically Suppressed on Regimens Containing ABC/3TC
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of switching abacavir/lamivudine (ABC/3TC) fixed-dose combination (FDC) tablets to emtricitabine/tenofovir alafenamide (F/TAF) FDC…
- Trial name
- NCT02469246
- Testing
- F/TAF, ABC/3TC, 3rd ARV agent
- Where
- 80 sites in United States, Belgium and 10 more
- Volunteers
- 567 people
- Sponsor
- Gilead Sciences
Lymphangioleiomyomatosis
A Study to Determine the Safety and Effectiveness of RAD001 (Everolimus) in Patients With Lymphangioleiomyomatosis
This was an exploratory study to determine whether escalating doses of RAD001 (everolimus) were safe and effective in patients with Lymphangioleiomyomatosis
- Trial name
- NCT01059318
- Testing
- Everolimus
- Where
- 4 sites in United States, France and 1 more
- Volunteers
- 24 people
- Sponsor
- Novartis Pharmaceuticals
Tuberous Sclerosis Complex (TSC), Lymphangioleiomyomatosis (LAM)
Efficacy and Safety of RAD001 in Patients Aged 18 and Over With Angiomyolipoma Associated With Either Tuberous Sclerosis Complex (TSC) or Sporadic Lymphangioleiomyomatosis (LAM)
This study will evaluate the safety and efficacy of RAD001 in treating patients with Angiomyolipoma associated with Tuberous Sclerosis Complex or Sporadic Lymphangioleiomyomatosis.
- Trial name
- EXIST-2 (NCT00790400)
- Testing
- Everolimus (RAD001)
- Where
- 25 sites in United States, Canada and 9 more
- Volunteers
- 118 people
- Sponsor
- Novartis Pharmaceuticals
Hepatitis C, HIV
Part A: Drug Interaction Study of Sofosbuvir and Antiretroviral Therapy (ART) Combinations in HIV and Hepatitis C Virus (HCV) Co-infected Patients. Part B: Efficacy and Safety of Sofosbuvir for 12 Weeks in HIV/HCV Co-infected Patients.
This study consists of 2 parts, Part A and Part B. Part A, the Phase 1 drug interaction/early viral kinetic study, will evaluate the effect of selected antiretroviral therapies on the safety, viral kinetics, and pharmacokinetics…
- Trial name
- NCT01565889
- Testing
- SOF, EFV/FTC/TDF, EFV
- Where
- Puerto Rico
- Volunteers
- 52 people
- Sponsor
- Gilead Sciences
Human Immunodeficiency Virus
Efficacy Study of Different Laboratory Management Strategies and Drug Regimens in HIV-infected Children in Africa
The two original objectives were to determine in HIV-infected children initiating antiretroviral therapy (ART): 1. Whether clinically driven monitoring (CDM) will have a similar outcome in terms of disease progression or death as…
- Trial name
- ARROW (NCT02028676)
- Testing
- Clinically Driven Monitoring (CDM), Laboratory plus Clinical Monitoring (LCM), Arm A: ABC+3TC+NNRTI
- Where
- 4 sites in Uganda, Zimbabwe
- Volunteers
- 1,206 people
- Sponsor
- Medical Research Council
HIV-1-infection
Dolutegravir-Lamivudine for naïve HIV-Infected Patients With ≤200 CD4/mm3
Protocol Title: DOLCE: Dolutegravir-Lamivudine for naïve HIV-Infected Patients with ≤200 CD4/mm3 Protocol Number: FH-57 Study Objectives: To assess the antiviral activity at week 48 of DTG+3TC among naïve HIV patients with a CD4…
- Trial name
- DOLCE (NCT04880395)
- Testing
- Intervention Arm: dolutegravir/lamivudine, Comparator ARM: TDF/XTC plus Dolutegravir (XTC stand for lamivudine OR emtricitabine)
- Where
- 11 sites in Argentina, Brazil
- Volunteers
- 265 people
- Sponsor
- Fundación Huésped
Lactic Acidosis
Lactic Acidosis During Entecavir(ETV)Treatment
The purpose of this study is to investigate whether entecavir treatment increases the incidence of lactic acidosis compared to another nucleoside/nucleotide reverse transcriptase inhibitors (NRTI), lamivudine, and/or no NRTI…
- Trial name
- ETV (NCT01354652)
- Testing
- entecavir, lamivudine
- Volunteers
- 5 people
- Sponsor
- Asan Medical Center
HIV Infections
The Pharmacokinetics, Safety, and Tolerability of Abacavir/Dolutegravir/Lamivudine Dispersible and Immediate Release Tablets in HIV-1-Infected Children Less Than 12 Years of Age
The purpose of this study was to examine the pharmacokinetics, safety, and tolerability of abacavir/dolutegravir/lamivudine dispersible and immediate release tablets in children living with HIV less than 12 years of age.
- Trial name
- NCT03760458
- Testing
- Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Dispersible Tablets, Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC) Immediate Release Tablets (Immediate release)
- Where
- 14 sites in United States, Botswana and 2 more
- Volunteers
- 57 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
HIV
Combivir And Maraviroc In Antiretroviral Naive Subjects In Russia
One hundred subjects in Russia will be treated with a combination of Combivir (zidovudine and lamivudine) and maraviroc as their first line HIV therapy.
- Trial name
- NCT01275625
- Testing
- HIV therapy
- Where
- 8 sites in Russia
- Volunteers
- 98 people
- Sponsor
- ViiV Healthcare
Hepatitis B, Chronic
Entecavir Plus Adefovir in Lamivudine-Resistant Chronic Hepatitis B Patients Who Fail Lamivudine Plus Adefovir
The presence of persistent inadequate or suboptimal virologic response is a strong risk factor for viral resistance and breakthrough and also for disease progression of chronic hepatitis B, and thus, a change in therapy is…
- Trial name
- CAESAR (NCT01023217)
- Testing
- Adefovir, Entecavir, Lamivudine
- Where
- South Korea
- Volunteers
- 90 people
- Sponsor
- Asan Medical Center
HIV Infection
Abacavir/Lamivudine Versus Emtricitabine/Tenofovir Both In Combination With Lopinavir/Ritonavir For The Treatment Of HIV
This study was designed to test the safety and effectiveness of EPZICOM(abacavir/lamivudine) and TRUVADA (emtricitabine/tenofovir) for the treatment of HIV infection when both are used in combination with KALETRA…
- Trial name
- HEAT (NCT00244712)
- Testing
- emtricitabine/tenofovir, abacavir/lamivudine
- Where
- 74 sites in United States, Puerto Rico
- Volunteers
- 688 people
- Sponsor
- GlaxoSmithKline
Infection, Human Immunodeficiency Virus I
A Trial Comparing GSK1349572 50mg Plus Abacavir/Lamivudine Once Daily to Atripla (Also Called The SINGLE Trial)
The purpose of this trial is to assess the non-inferior antiviral activity of GSK1349572 50 mg plus Abacavir/Lamivudine once daily versus Efavirenz/Emtricitabine/Tenofovir disoproxil fumarate (ATRIPLA® a trade mark of…
- Trial name
- NCT01263015
- Testing
- Dolutegravir, Atripla, Abacavir/Lamivudine
- Where
- 145 sites in United States, Australia and 10 more
- Volunteers
- 844 people
- Sponsor
- ViiV Healthcare
HIV Infections, Acquired Immunodeficiency Syndrome
A Study to Evaluate the Safety and Efficacy of an Investigational Drug in HIV Infected Patients (0518-004)(COMPLETED)
This is a study that will investigate the safety and efficacy of an investigational drug in Human immunodeficiency virus (HIV) infected patients.
- Trial name
- NCT00100048
- Testing
- Comparator: MK0518 monotherapy, Comparator: MK0518 combination therapy, Comparator: efavirenz
- Volunteers
- 206 people
- Sponsor
- Merck Sharp & Dohme LLC
HIV Infections
Study to Evaluate the Efficacy, Safety, and Tolerability of Long-acting Intramuscular Cabotegravir and Rilpivirine for Maintenance of Virologic Suppression Following Switch From an Integrase Inhibitor in HIV-1 Infected Therapy Naive Participants
The First Long-Acting Injectable Regimen (FLAIR) study is being conducted to establish if human immunodeficiency virus type-1 (HIV-1) infected adult participants whose virus is virologically suppressed on an integrase inhibitor…
- Trial name
- NCT02938520
- Testing
- Cabotegravir (CAB) tablet, Rilpivirine (RPV) tablet, Cabotegravir - Injectable Suspension (CAB LA)
- Where
- 108 sites in United States, Canada and 9 more
- Volunteers
- 631 people
- Sponsor
- ViiV Healthcare
HIV Infections
Tenofovir-lamivudine-dolutegravir Combination as Second-line ART: a Randomised Controlled Trial
The strategy to support virological suppression on second-line antiretroviral treatment (ART) includes the provision of ART that has a low pill burden, good tolerability, low toxicity, is easily monitored, has a high barrier to…
- Trial name
- ARTIST (NCT03991013)
- Testing
- Dolutegravir 50 mg
- Where
- South Africa
- Volunteers
- 192 people
- Sponsor
- University of Cape Town
Hepatitis B
Tenofovir Disoproxil Fumarate (Tenofovir DF) Versus Emtricitabine/Tenofovir DF in Subjects Resistant to Lamivudine
The aim of therapy for the treatment of chronic hepatitis B virus (HBV) is to maintain suppression of viral replication to prevent the emergence of complications, which requires long-term therapy.
- Trial name
- NCT00737568
- Testing
- TDF, FTC/TDF
- Where
- 69 sites in United States, Austria and 12 more
- Volunteers
- 280 people
- Sponsor
- Gilead Sciences
HIV Infections, HIV-1-infection
Simplification Study of HIV-1 Infected Patients With Virological Suppression Under the Combination of Lamivudine (150 mg BID) Plus Raltegravir (400 mg BID) Switching to Lamivudine (300 mg QD) Plus Raltegravir (1200 mg QD) : Roll-over Study of the RALAM
Phase 3b, single arm, single site simplification study of HIV-1 infected patients with virological suppression under the combination of Lamivudine (150 mg BID) plus Raltegravir (400 mg BID) switching to Lamivudine (300 mg QD)…
- Conditions
- HIV Infections, HIV-1-infection, HIV Seropositivity
- Trial name
- NCT03311945
- Testing
- Raltegravir, Lamivudine
- Where
- Spain
- Volunteers
- 33 people
- Sponsor
- Judit Pich
HIV Infections
A Dose-Range Finding Clinical Trial Study in Human Immunodeficiency Virus (HIV-1) Infected Treatment-Naive Adults
This is a phase 2b, randomized, multicenter, parallel group, partially blind (to GSK3640254 doses [100, 150 and 200 milligrams {mg}]), active controlled clinical trial.
- Trial name
- DOMINO (NCT04493216)
- Testing
- GSK3640254, ABC/3TC, FTC/TAF
- Where
- 65 sites in United States, Argentina and 9 more
- Volunteers
- 161 people
- Sponsor
- ViiV Healthcare
HIV Positive, Malnourished
IMPAACT P1092: Steady State PK in Malnourished HIV Infected Children
Children living with HIV from sub-Saharan Africa often present with severe malnutrition. In severe malnutrition, metabolic and/or gut structural derangement may lead to inadequate antiretroviral (ARV) absorption and/or erratic…
- Trial name
- NCT01818258
- Testing
- ZDV+3TC+LPV/r
- Where
- 5 sites in Malawi, Tanzania and 2 more
- Volunteers
- 52 people
- Sponsor
- International Maternal Pediatric Adolescent AIDS Clinical Trials Group