HIV Infections Clinical Trial
Official title:
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
Verified date | March 2021 |
Source | Gilead Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The primary objective of this study is to evaluate the non-inferiority of switching to a tenofovir alafenamide (TAF)-containing fixed dose combination (FDC) relative to maintaining tenofovir disoproxil fumarate (TDF)-containing combination regimens in virologically suppressed HIV-infected participants as determined by having HIV-1 RNA < 50 copies/mL at Week 48.
Status | Completed |
Enrollment | 1443 |
Est. completion date | April 1, 2020 |
Est. primary completion date | March 16, 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Key Inclusion Criteria: - Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures - Currently receiving antiretroviral therapy consisting of E/C/F/TDF, EFV/FTC/TDF, RTV+ATV+FTC/TDF, or COBI+ATV+FTC/TDF for = 6 consecutive months preceding the final visit in their earlier study - Completion of the Week 144 visit in studies GS-US-236-0102, GS-US-236-0103, GS-US-216-0114, or completion of the Week 96 visit in study GS-US-264-0110 (only participants on an EFV-based regimen), or completion of studies GS-US-236-0104, GS-US-216-0105 - Plasma human immunodeficiency virus type 1-ribonucleic acid (HIV-1 RNA) concentrations at undetectable levels for at least 6 consecutive months prior to the screening visit and have HIV RNA < 50 copies/mL at the screening visit - Normal echocardiograph (ECG) - Estimated glomerular filtration rate (GFR) = 50 mL/min according to the Cockcroft-Gault formula for creatinine clearance - Hepatic transaminases (aspartate aminotransferase [AST] and alanine aminotransferase [ALT]) = 5 × upper limit of the normal range (ULN) - Direct bilirubin = 1.5 x ULN - Adequate hematologic function - Serum amylase = 5 × ULN - Females of childbearing potential must agree to utilize highly effective contraception methods or be non-heterosexually active or practice sexual abstinence from screening throughout the duration of study treatment and for 12 weeks following the last dose of study drug if receiving EFV/FTC/TDF regimen, and 30 days for those assigned to all other regimens. - Female participants who utilize hormonal contraceptive as one of their birth control methods must have used the same method for at least three months prior to study dosing - Female participants who have stopped menstruating for = 12 months but do not have documentation of ovarian hormonal failure must have a serum follicle stimulating hormone (FSH) level at screening within the post-menopausal range based on the Central Laboratory reference range Key Exclusion Criteria: - A new acquired immunodeficiency syndrome (AIDS)-defining condition diagnosed within the 30 days prior to screening - Hepatitis B surface antigen position - Hepatitis C antibody positive - Participants experiencing decompensated cirrhosis - Females who are breastfeeding - Positive serum pregnancy test - Have an implanted defibrillator or pacemaker - Current alcohol or substance use judged by the Investigator to potentially interfere with subject study compliance - History of malignancy within the past 5 years or ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, noninvasive cutaneous squamous carcinoma - Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to baseline - Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with dosing requirements - Participation in any other clinical trial without prior approval from the sponsor is prohibited while participating in this trial - Participants receiving ongoing therapy with drugs not to be used with elvitegravir (EVG), COBI, FTC, TDF, ATV, RTV, EFV, and TAF or participants with any known allergies to the excipients of E/C/F/TDF, E/C/F/TAF, EFV/FTC/TDF, ATV, COBI, RTV, or FTC/TDF Note: Other protocol defined Inclusion/Exclusion criteria may apply. |
Country | Name | City | State |
---|---|---|---|
Australia | Melbourne Sexual Health Clinic | Carlton | Victoria |
Australia | East Sydney Doctors | Darlinghurst | New South Wales |
Australia | Holdsworth House Medical practice | Darlinghurst | New South Wales |
Australia | St Vincent's Hospital, Sydney | Darlinghurst | New South Wales |
Australia | Taylor Square Private Clinic | Darlinghurst | New South Wales |
Australia | Alfred Hospital | Melbourne | Victoria |
Australia | Northside Clinic | Melbourne | Victoria |
Australia | Prahran Market Clinic | South Yarra | Victoria |
Australia | Albion Street Centre | Surry Hills | New South Wales |
Austria | Medizinische Universität Graz | Graz | |
Austria | Medizinische Universitat Wien | Vienna | |
Austria | SMZ Baumgartner Hoehe - Otto-Wagner-Spital | Vienna | |
Belgium | CHU Saint-Pierre University Hospital | Brussels | |
Belgium | Hôpital Universitaire Erasme - ULB | Ghent | |
Brazil | Instituto De Pesquisa Clinica Evandro Chagas - Fundação Oswaldo Cruz | Rio de Janeiro | |
Brazil | Faculdade de Medicina do ABC | Santo Andre | |
Brazil | São Paulo Secretaria da Saúde - Centro de Referência e Treinamento em DST/AIDS | Sao Paulo | |
Brazil | São Paulo Secretaria da Saúde - Instituto De Infectologia Emilio Ribas | Sao Paulo | |
Canada | Clinique Medicale du Quartier Latin | Montreal | Quebec |
Canada | Clinique medicale l'Actuel | Montreal | Quebec |
Canada | Clinique OPUS | Montreal | Quebec |
Canada | McGill University Health Centre (MUHC) - Montral Chest Institute | Montréal | Quebec |
Canada | Ottawa Hospital | Ottawa | Ontario |
Canada | Maple Leaf Research | Toronto | Ontario |
Canada | Sunnybrook Health Sciences Centre | Toronto | Ontario |
Canada | University Health Network, Toronto General Hospital | Toronto | Ontario |
Canada | Ubc Downtown I.D. Clinic | Vancouver | British Columbia |
Canada | Winnipeg Regional Health Authority - Health Sciences Centre Winnipeg | Winnipeg | Manitoba |
Denmark | Epidemiklinikken 5112, Rigshospitalet | Copenhagen | |
Dominican Republic | Instituto Dominicano de Estudios Virologicos - IDEV | Santo Domingo | |
France | Hôpital de La Croix Rousse | Lyon | |
France | CHU Hotel Dieu | Nantes | |
France | Archet 1 CHU de Nice - 6ème Niveau | Nice | |
France | Bichat Hospital | Paris | |
France | Hopital Saint Antoine | Paris | |
France | Hôpital Saint Louis | Paris | |
France | Centre Hospitalier de Tourcoing | Tourcoing | |
Germany | EPIMED GmbH | Berlin | |
Germany | University of Bonn | Bonn | |
Germany | Center for HIV and Hepatogastroenterology | Duesseldorf | |
Germany | Infektio Research GmbH / Infektiologikum Frankfurt | Frankfurt am Main | |
Germany | Universitätsklinikum Frankfurt | Frankfurt am Main | |
Germany | Universitatsklinikum Freiburg | Freiburg | |
Germany | ICH Study Center Hamburg | Hamburg | |
Germany | University Medical Center Hamburg-Eppendorf, Infectious Diseases Unit | Hamburg | |
Germany | University of Cologne, Department of Internal Medicine | Köln | |
Germany | MUC Research GmbH | München | |
Italy | Fondazione Centro San Raffaele del Monte Tabor | Milan | |
Italy | Azienda Ospedaliera Luigi Sacco 1° Divisione Malattie Infettive | Milano | |
Italy | Istituto Nazionale Malattie Infettive "Lazzaro Spallanzani" IRCCS | Rome | |
Italy | Comprensorio Amedeo Di Savoia Birago Di Vische | Torino | |
Mexico | Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde" | Guadalajara | |
Netherlands | Onze Lieve Vrouwe Gasthuis, Afdeling Infectieziekten | Amsterdam | |
Netherlands | Erasmus MC | Rotterdam | |
Portugal | Hospital de Santa Maria | Lisbon | |
Portugal | Servico De Doencas Infecciosas - Hospital De Sao Joao | Porto | |
Puerto Rico | Clinical Research Puerto Rico | San Juan | |
Puerto Rico | HOPE Clinical Research | San Juan | |
Puerto Rico | VA Caribbean Healthcare System | San Juan | |
Spain | Hospital Universitari De Bellvitge | Barcelona | |
Spain | Hospital Universitario La Paz | Madrid | |
Spain | Hospital Virgen del Rocio | Sevilla | |
Sweden | Södersjukhuset | Stockholm | |
Switzerland | Universitätsklinik für Infektiologie, Universitätsspital Bern | Bern | |
Switzerland | Centre Hospitalier Universitaire Vaudois | Lausanne | |
Switzerland | University Hospital of Zurich | Zürich | |
Thailand | HIV-NAT, Thai Red Cross AIDS Research Center and Faculty of Medicine Chulalongkorn University | Bangkok | |
Thailand | Ramathibodi Hospital, Mahidol University | Bangkok | |
Thailand | Siriraj HospitalDepartment of Preventive and Social Medicine, Faculty of Medicine | Bangkok | |
Thailand | Maharaj Nakorn Chiang Mai University, Faculty of Medicine, Department of Medicine | Chiang Mai | |
Thailand | Khon Kaen University | Khon Kaen | |
United Kingdom | Brighton and Sussex University Hospitals NHS Trust | Brighton | |
United Kingdom | Barts and the London NHS Trust | London | |
United Kingdom | Chelsea and Westminster Hospital Foundation Trust | London | |
United Kingdom | Courtyard Clinic, St. Georges Hospital | London | |
United Kingdom | North Manchester General Hospital | Manchester | |
United States | Summa Health System | Akron | Ohio |
United States | Albany Medical College | Albany | New York |
United States | Upstate ID Association | Albany | New York |
United States | Clinical Alliance for Research & Education, Infectious Diseases (CARE-ID) | Annandale | Virginia |
United States | AIDS Research Consortium of Atlanta | Atlanta | Georgia |
United States | Atlanta ID Group, PC | Atlanta | Georgia |
United States | Be Well Medical Center | Berkley | Michigan |
United States | AHF Research Center | Beverly Hills | California |
United States | University of Alabama at Birmingham | Birmingham | Alabama |
United States | Community Research Initiative of New England | Boston | Massachusetts |
United States | Jacobi Medical Center | Bronx | New York |
United States | Montefiore Medical Center - AIDS Center | Bronx | New York |
United States | University of NC AIDS Clinical Trials Unit | Chapel Hill | North Carolina |
United States | Carolinas Medical Center-Myers Park | Charlotte | North Carolina |
United States | Howard Brown Health Center | Chicago | Illinois |
United States | NorthStar Medical Center | Chicago | Illinois |
United States | Ruth M. Rothstein CORE Center | Chicago | Illinois |
United States | Palmetto Health Richland | Columbia | South Carolina |
United States | Michael Keith Wensley, MD, Inc., A Medical Corporation | Costa Mesa | California |
United States | AIDS Arms, Inc./ Peabody Health Center | Dallas | Texas |
United States | Southwest Infectious Disease Clinical Research, Inc. | Dallas | Texas |
United States | Infectious Disease Specialists of Atlanta | Decatur | Georgia |
United States | Apex Research LLC | Denver | Colorado |
United States | Henry Ford Health System | Detroit | Michigan |
United States | Duke University Health System | Durham | North Carolina |
United States | New York Hospital Queens | Flushing | New York |
United States | Broward Health/Comprehensive Care Center | Fort Lauderdale | Florida |
United States | Gary J. Richmond,M.D.,P.A. | Fort Lauderdale | Florida |
United States | Therafirst Medical Center | Fort Lauderdale | Florida |
United States | Midway Immunology and Research Center | Fort Pierce | Florida |
United States | Tarrant County Infectious Disease Associates | Fort Worth | Texas |
United States | East Carolina University | Greenville | North Carolina |
United States | Greenwich Hospital | Greenwich | Connecticut |
United States | Garcia's Family Health Group | Harlingen | Texas |
United States | ID Care | Hillsborough | New Jersey |
United States | University of Hawaii - Hawaii Center for AIDS | Honolulu | Hawaii |
United States | Gordon E. Crofoot MD PA | Houston | Texas |
United States | Research Access Network | Houston | Texas |
United States | Therapeutic Concepts, P.A. | Houston | Texas |
United States | Rosedale Infectious Diseases | Huntersville | North Carolina |
United States | Health for Life Clinic PLLC | Little Rock | Arkansas |
United States | Living Hope Clinical Foundation | Long Beach | California |
United States | DCOL Center for Clinical Research | Longview | Texas |
United States | Anthony Mills MD Inc | Los Angeles | California |
United States | Jeffrey Goodman Special Care Clinic | Los Angeles | California |
United States | Kaiser Permanente | Los Angeles | California |
United States | Peter J Ruane, MD, Inc | Los Angeles | California |
United States | Mercer University School of Medicine | Macon | Georgia |
United States | North Shore University Hospital, Divison of Infectious Diseases | Manhasset | New York |
United States | The Kinder Medical Group | Miami | Florida |
United States | Wohlfeiler, Piperato and Associates, LLC | Miami Beach | Florida |
United States | Medical College of Wisconsin | Milwaukee | Wisconsin |
United States | Hennepin County Medical Center | Minneapolis | Minnesota |
United States | Greiger Clinic | Mount Vernon | New York |
United States | Yale University HIV Clinical Trials Program | New Haven | Connecticut |
United States | Beth Israel Medical Center- Division of Infectious Diseases | New York | New York |
United States | Chelsea Village Medical, PC | New York | New York |
United States | Ricky K. Hsu, MD | New York | New York |
United States | Saint Michaels Medical Center | Newark | New Jersey |
United States | Orange Coast Medical Group | Newport Beach | California |
United States | Alameda County Medical Center | Oakland | California |
United States | East Bay AIDS Center | Oakland | California |
United States | IDOCF/ Value Health MD, LLC | Orlando | Florida |
United States | Orlando Immunology Center | Orlando | Florida |
United States | Stanford University | Palo Alto | California |
United States | Thomas Jefferson University | Philadelphia | Pennsylvania |
United States | University of Pennsylvania | Philadelphia | Pennsylvania |
United States | Southwest Center for HIV/AIDS | Phoenix | Arizona |
United States | Spectrum Medical Group | Phoenix | Arizona |
United States | Kaiser Permanente Medical Group | Sacramento | California |
United States | University of California, Davis Medical Center | Sacramento | California |
United States | Central West Clinical Research | Saint Louis | Missouri |
United States | Saint Louis University | Saint Louis | Missouri |
United States | Southampton Healthcare | Saint Louis | Missouri |
United States | La Playa Medical Group and Clinical Research | San Diego | California |
United States | Kaiser Permanente Medical Center, Clinical Trials Unit | San Francisco | California |
United States | Metropolis Medical Group | San Francisco | California |
United States | Kaiser Permanente Hospital | San Leandro | California |
United States | SouthWest CARE Center | Santa Fe | New Mexico |
United States | Peter Shalit, M.D. | Seattle | Washington |
United States | South Jersey Infectious Disease | Somers Point | New Jersey |
United States | Premier Clinical Research | Spokane | Washington |
United States | Baystate Infectious Diseases Clinical Research | Springfield | Massachusetts |
United States | The Research Institute | Springfield | Massachusetts |
United States | Infectious Disease Research Institute Inc. | Tampa | Florida |
United States | St. Joseph's Comprehensive Research Institute | Tampa | Florida |
United States | University of South Florida HIV Clinical Research Unit / Hillsborough County Health Department | Tampa | Florida |
United States | Capital Medical Associates, PC | Washington | District of Columbia |
United States | Dupont Circle Physicians Group | Washington | District of Columbia |
United States | George Washington University Medical Faculty Associates | Washington | District of Columbia |
United States | Whitman Walker Clinic | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Gilead Sciences |
United States, Australia, Austria, Belgium, Brazil, Canada, Denmark, Dominican Republic, France, Germany, Italy, Mexico, Netherlands, Portugal, Puerto Rico, Spain, Sweden, Switzerland, Thailand, United Kingdom,
Abram M, Margot NA, Cox S, Ram RR, et al. Pooled week-48 analysis of HIV-1 drug resistance in E/C/F/TAF (Genvoya) phase 3 studies. 23rd Annual Conference on Retroviruses and Opportunistic Infections (CROI) - CROI Foundation 2016, poster presentation: abst
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Viciana P, Mills A, Andrade J, Diperri G, et al. Switching from a tenofovir disoproxil fumarate (TDF)-based regimen to a tenofovir alafenamide (TAF)-based regimen: data in virologically suppressed adults through 48 weeks of treatment. 7th National Congres
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* Note: There are 40 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 | The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. | Week 48 | |
Secondary | Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48 | Hip BMD was assessed by dual energy x-ray absorptiometry (DXA) scan. BMD is calculated as grams per square centimeter (g/cm^2); the mean (SD) percentage change is presented. | Baseline; Week 48 | |
Secondary | Percent Change From Baseline in Spine BMD at Week 48 | Spine BMD was assessed by DXA scan. BMD is calculated as g/cm^2; the mean (SD) percentage change is presented. | Baseline; Week 48 | |
Secondary | Change From Baseline in Serum Creatinine at Week 48 | Baseline; Week 48 | ||
Secondary | Change From Baseline in the Overall EFV-related Symptom Assessment Score at Week 48 | The mean (SD) change of the overall EFV-related symptom assessment score is presented. The overall symptom score (ranging from 0 to 20) is the sum of the individual symptom scores ranging from 0 (no symptoms) to 4 (most severe symptoms) from the 5 EFV-related symptom assessments (dizziness, trouble sleeping, impaired concentration, sleepiness, and abnormal or vivid dream). A negative change from baseline indicates improvement.
EFV-Related Symptom Analysis Set: participants who received EFV/FTC/TDF as prior treatment, received at least 1 dose of study drug, and completed EFV-related symptom assessments at the baseline visit and at least 1 postbaseline visit. |
Baseline; Week 48 | |
Secondary | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 | The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. | Week 96 | |
Secondary | Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Week 48 | The percentage of participants achieving HIV-1 RNA < 20 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. | Week 48 | |
Secondary | Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Week 96 | The percentage of participants achieving HIV-1 RNA < 20 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. | Week 96 | |
Secondary | Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Week 48 | The analysis of CD4 cell count included values up to 1 day after the last dose date of randomized study drug.The change from baseline in CD4 cell count for the full analysis set was based on observed data (ie, Missing = Excluded) for the total and by the prior treatment regimen. | Baseline; Week 48 | |
Secondary | Change From Baseline in CD4 Cell Count at Weeks 96 | The analysis of CD4 cell count included values up to 1 day after the last dose date of randomized study drug.The change from baseline in CD4 cell count for the full analysis set was based on observed data (ie, Missing = Excluded) for the total and by the prior treatment regimen. | Baseline; Week 96 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05454514 -
Automated Medication Platform With Video Observation and Facial Recognition to Improve Adherence to Antiretroviral Therapy in Patients With HIV/AIDS
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N/A | |
Completed |
NCT03760458 -
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
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Phase 1/Phase 2 | |
Completed |
NCT03067285 -
A Phase IV, Open-label, Randomised, Pilot Clinical Trial Designed to Evaluate the Potential Neurotoxicity of Dolutegravir/Lamivudine/Abacavir in Neurosymptomatic HIV Patients and Its Reversibility After Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide. DREAM Study
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Phase 4 | |
Completed |
NCT03141918 -
Effect of Supplementation of Bioactive Compounds on the Energy Metabolism of People Living With HIV / AIDS
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N/A | |
Recruiting |
NCT04579146 -
Coronary Artery Disease (CAD) in Patients HIV-infected
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Completed |
NCT06212531 -
Papuan Indigenous Model of Male Circumcision
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N/A | |
Active, not recruiting |
NCT03256422 -
Antiretroviral Treatment Taken 4 Days Per Week Versus Continuous Therapy 7/7 Days Per Week in HIV-1 Infected Patients
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Phase 3 | |
Completed |
NCT03256435 -
Retention in PrEP Care for African American MSM in Mississippi
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N/A | |
Completed |
NCT00517803 -
Micronutrient Supplemented Probiotic Yogurt for HIV/AIDS and Other Immunodeficiencies
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N/A | |
Active, not recruiting |
NCT03572335 -
Systems Biology of Diffusion Impairment in Human Immunodeficiency Virus (HIV)
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Completed |
NCT04165200 -
Fecal Microbiota Transplantation as a Therapeutic Strategy for Patients Infected With HIV
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N/A | |
Recruiting |
NCT03854630 -
Hepatitis B Virus Vaccination in HIV-positive Patients and Individuals at High Risk for HIV Infection
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Phase 4 | |
Terminated |
NCT03275571 -
HIV, Computerized Depression Therapy & Cognition
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N/A | |
Completed |
NCT02234882 -
Study on Pharmacokinetics
|
Phase 1 | |
Completed |
NCT01618305 -
Evaluating the Response to Two Antiretroviral Medication Regimens in HIV-Infected Pregnant Women, Who Begin Antiretroviral Therapy Between 20 and 36 Weeks of Pregnancy, for the Prevention of Mother-to-Child Transmission
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Phase 4 | |
Recruiting |
NCT05043129 -
Safety and Immune Response of COVID-19 Vaccination in Patients With HIV Infection
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Not yet recruiting |
NCT05536466 -
The Influence of Having Bariatric Surgery on the Pharmacokinetics, Safety and Efficacy of the Novel Non-nucleoside Reverse Transcriptase Inhibitor Doravirine
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N/A | |
Recruiting |
NCT04985760 -
Evaluation of Trimer 4571 Therapeutic Vaccination in Adults Living With HIV on Suppressive Antiretroviral Therapy
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Phase 1 | |
Completed |
NCT05916989 -
Stimulant Use and Methylation in HIV
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||
Terminated |
NCT02116660 -
Evaluation of Renal Function, Efficacy, and Safety When Switching From Tenofovir/Emtricitabine Plus a Protease Inhibitor/Ritonavir, to a Combination of Raltegravir (MK-0518) Plus Nevirapine Plus Lamivudine in HIV-1 Participants With Suppressed Viremia and Impaired Renal Function (MK-0518-284)
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Phase 2 |