Dolutegravir-Lamivudine as Dual Therapy in naïve HIV-Infected Patients With Documented M184V Mutation:A Pilot Study
NCT05295394 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL
Last updated 2022-04-12
Summary
The purpose of this study is to evaluate the antiviral efficacy, safety and tolerability of dual therapy with 3TC and DTG as initial therapy among naïve HIV patients with a documented M184V mutation.
Conditions
- HIV-1 Infection
Interventions
- DRUG
-
Dolutegravir plus lamivudine
Dolutegravir 50 mg QD plus lamivudine 300 mg QD
Sponsors & Collaborators
-
ViiV Healthcare
collaborator INDUSTRY -
Pedro Cahn
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2019-05-22
- Primary Completion
- 2022-08-31
- Completion
- 2022-08-30
Countries
- Argentina
Study Locations
More Related Trials
-
A Clinical Trial of GSK3640254 + Dolutegravir (DTG) in Human Immunodeficiency Virus-1 Infected Treatment-naive Adults
NCT04900038 ·Status: TERMINATED ·Phase: PHASE2
-
Efficacy of Dolutegravir Plus Lamivudine in HIV-1-infected Treatment-naïve Adults Without a Baseline Genotyping Test
NCT04549467 ·Status: COMPLETED ·Phase: PHASE4
-
TMC114-C209: A Study of Safety of TMC114 With Low Dose Ritonavir (RTV) and Other Antiretrovirals in Experienced HIV-1 Infected Patients With Limited or no Treatment Options
NCT00115050 ·Status: COMPLETED ·Phase: PHASE3
-
Triple vs. Double Therapy in naïves HIV-Infected Patients
NCT04295460 ·Status: UNKNOWN ·Phase: PHASE4
-
A Study to Evaluate the Safety and Efficacy of Raltegravir (MK0518) in HIV-Infected Patients Failing Current Antiretroviral Therapies (0518-019)
NCT00293254 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Effectiveness of Giving Indinavir, Ritonavir, Stavudine, and Lamivudine to HIV-Infected Patients Who Have Never Received Anti-HIV Drugs
NCT00002451 ·Status: UNKNOWN ·Phase: PHASE2
-
A Study to Evaluate the Efficacy, Safety, and Tolerability of Using an Oral Once-daily 2 Drug Regimen Compared to an Oral Once-daily 3 Drug Regimen for the Treatment of Human Immunodeficiency Virus (HIV)-1 in Adults Who Have Not Previously Taken Antiretroviral Therapy
NCT05979311 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
TMC114-C226: An Early Access Program to Evaluate the Long-term Safety and Tolerability of TMC114 Combined With a Low Dose of Ritonavir (TMC114/r) With Other Antiretrovirals, for HIV-1 Infected Patients Who Have Failed Multiple Antiretroviral Regimens.
NCT00245739 ·Status: APPROVED_FOR_MARKETING
-
A Phase III Randomized Double-Blind, Multicenter Study to Evaluate the Safety and Efficacy of 3TC/ZDV/1592U89 and 3TC/ZDV/IDV in HIV-1 Infected Antiretroviral Therapy-Naive Subjects.
NCT00002199 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Efficacy of a Switch to Doravirine, Tenofovir, Lamivudine (MK-1439A) in Human Immunodeficiency Virus (HIV-1)-Infected Participants Virologically Suppressed on an Anti-retroviral Regimen in Combination With Two Nucleoside Reverse Transcriptase Inhibitors (MK-1439A-024)
NCT02397096 ·Status: COMPLETED ·Phase: PHASE3
-
Study of Once Daily Elvucitabine Versus Lamivudine in Participants With a Documented M184V Mutation
NCT00312039 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
The Safety and Effectiveness of Indinavir Plus Ritonavir Plus Two NRTIs in HIV-Infected Patients Who Need Early Intervention Treatment
NCT00005118 ·Status: UNKNOWN ·Phase: PHASE2
-
Dose Ranging Study of GSK1265744 Plus Nucleoside Reverse Transcriptase Inhibitors for Induction of Human Immunodeficiency Virus-1 (HIV-1) Virologic Suppression Followed by Virologic Suppression Maintenance by GSK1265744 Plus Rilpivirine
NCT01641809 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of 141W94 Used Alone or in Combination With Zidovudine Plus 3TC in HIV-Infected Patients
NCT00001085 ·Status: COMPLETED ·Phase: PHASE2
-
Dolutegravir Plus Lamivudine Dual Therapy in Treatment Naïve HIV-1 Patients
NCT02582684 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of Retrovir and Epivir Alone or in Combination With 141W94 in HIV-Infected Patients
NCT00002195 ·Status: COMPLETED ·Phase: PHASE3
-
Comparing the Safety, Effectiveness, and Tolerability of Three Anti-HIV Drug Regimens for Treatment-Naive Patients
NCT00050895 ·Status: COMPLETED ·Phase: PHASE3
-
Virologic and Immunologic Activity of Continued Lamivudine (3TC) vs Delavirdine (DLV) in Combination With Indinavir (IDV) and Zidovudine (ZDV) or Stavudine (d4T) in 3TC-Experienced Subjects
NCT00000882 ·Status: COMPLETED ·Phase: PHASE2
-
TMC125-C216: A Phase III Study to Investigate the Efficacy, Tolerability and Safety of TMC125 as Part of an Antiretroviral Regimen, Including TMC114/Ritonavir and an Investigator-selected Optimized Background, in HIV-1 Infected Patients With Limited to no Treatment Options.
NCT00255099 ·Status: COMPLETED ·Phase: PHASE3
-
Rapid Test and Treat Dolutegravir Plus Lamivudine Study in Newly Diagnosed Human Immunodeficiency Virus (HIV)-1 Infected Adults
NCT03945981 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Investigate the Antiviral Effect, Safety, Tolerability and Pharmacokinetics of VH3739937 in in Treatment-Naive Adults Living With HIV-1
NCT06061081 ·Status: TERMINATED ·Phase: PHASE2
-
A Study to Evaluate Efficacy, Safety and Tolerability in Antiretroviral Therapy (ART)-Experienced Participants of at Least 50 Years of Age Living With Human Immunodeficiency Virus (HIV) With Virologic Suppression Who Switch to DTG/3TC FDC From BIC/FTC/TAF
NCT05911360 ·Status: COMPLETED ·Phase: PHASE3
-
The Safety and Effectiveness of Nevirapine Plus Lamivudine Plus Other Anti-HIV Drugs
NCT00002368 ·Status: COMPLETED ·Phase: PHASE3
-
A Safety and Efficacy Study of Amdoxovir in HIV-1 Treatment-experienced Subjects.
NCT01737359 ·Status: TERMINATED ·Phase: PHASE2
-
VH4524184 Proof-of-Concept in Treatment-Naïve Adults Living With HIV-1
NCT06214052 ·Status: COMPLETED ·Phase: PHASE2