Dual Therapy in HIV Patients in 4 Days a Week Versus 7 Days a Week
NCT04867083 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 440
Last updated 2021-11-08
Summary
The trial is an open-label, multicenter, prospective, randomized trial in 2 parallel groups, evaluating at W48 the non inferiority of antiretroviral dual therapy taken 4 consecutive days per week versus antiretroviral dual therapy 7/7 days per week in HIV-1 infected patients with controlled viral load under antiretroviral dual therapy.
Conditions
- HIV Infections
Interventions
- DRUG
-
ARV bitherapie
1. Dolutégravir 50mg / Lamivudine 300mg per day 2. Dolutégravir 50mg / Rilpivirine 25mg per day 3. Darunavir/r 800mg/100mg / Lamivudine 300mg per day
Sponsors & Collaborators
-
Institut National de la Santé Et de la Recherche Médicale, France
collaborator OTHER_GOV -
ANRS, Emerging Infectious Diseases
lead OTHER_GOV
Principal Investigators
-
Roland LANDMAN · Hôpital BICHAT
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 99 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-06-21
- Primary Completion
- 2023-07-31
- Completion
- 2024-07-31
Countries
- France
- Martinique
Study Locations
More Related Trials
-
Switching HIV-1 Infected Subjects From a Highly Active Anti-Retroviral Treatment (HAART) Regimen Dosed Twice Daily or More Frequently to a Once-Daily Regimen
NCT00135369 ·Status: COMPLETED ·Phase: PHASE3
-
Zidovudine / Lamivudine + Nevirapine Twice Daily, Versus Tenofovir + Lamivudine + Nevirapine Once Daily in ARV-Naive Patients
NCT00199979 ·Status: UNKNOWN ·Phase: PHASE3
-
A Comparison of Two Dose Levels of Indinavir Combined With Two Nucleoside Analogue Reverse Transcriptase Inhibitors (NRTIs) in HIV-Infected Patients
NCT00002406 ·Status: COMPLETED ·Phase: PHASE3
-
Effects on the Immune System of Anti-HIV Drugs in Patients Recently Infected With HIV
NCT00001119 ·Status: COMPLETED ·Phase: NA
-
A Dose Ranging Study Of GW640385 Boosted With Ritonavir (Rtv) In Comparison To A RTV-Boosted Protease Inhibitor (PI) In HIV-1 Infected PI-Experienced Adults
NCT00242879 ·Status: TERMINATED ·Phase: PHASE2
-
A Randomized, Double-Blind, Four-Arm Study Comparing Combination Nucleoside, Alternating Nucleoside, and Triple-Drug Therapy for the Treatment of Advanced HIV Disease (CD4 <= 50/mm3)
NCT00000781 ·Status: COMPLETED ·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
-
A Study of the Safety and Effectiveness of Combination Anti-HIV Therapy in HIV-Infected Adults
NCT00004585 ·Status: COMPLETED ·Phase: PHASE4
-
Clinical Trial to Evaluate the Efficacy and Safety of Codivir® in Addition to Standard Antiretroviral Treatment for HIV Infection in Antiretroviral-naïve Participants
NCT06676410 ·Status: RECRUITING ·Phase: PHASE2
-
A Comparison of Two Multi-Drug Therapies in HIV-Infected Patients Who Have Never Received Anti-HIV Treatment
NCT00002216 ·Status: COMPLETED ·Phase: NA
-
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
-
Triple vs. Double Therapy in naïves HIV-Infected Patients
NCT04295460 ·Status: UNKNOWN ·Phase: PHASE4
-
A Study of 141W94 in Combination With Other Anti-HIV Drugs
NCT00002372 ·Status: COMPLETED ·Phase: PHASE1
-
Study Of Investigational Regimen Combining FDA Approved HIV Drugs In HIV Subjects Experiencing Early Virologic Failure
NCT00038506 ·Status: COMPLETED ·Phase: PHASE4
-
To Investigate the Safety and Efficacy of UB-421 Monotherapy in HIV Infected Adults
NCT02369146 ·Status: COMPLETED ·Phase: PHASE2
-
A Clinical Study Of An Investigational Regimen Including Marketed HIV Drugs In HIV-1 Pediatric Subjects Ages 2-18 Years
NCT00040664 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of an Investigational Regimen Combining FDA Approved HIV Drugs in HIV-Infected Subjects
NCT00363142 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of Ritonavir-Boosted Invirase (Saquinavir) in Treatment-Naïve HIV-1 Infected Patients
NCT01638650 ·Status: COMPLETED ·Phase: PHASE1
-
Trial to Evaluate the Interest of a Reductive Anti Retroviral Strategy Using Dual Therapy Inspite of Triple Therapy
NCT02302547 ·Status: COMPLETED ·Phase: PHASE3
-
The Safety and Effectiveness of Retrovir Plus HIVID Combined With Either Nevirapine or Invirase in the Treatment of HIV Infection
NCT00002347 ·Status: COMPLETED ·Phase: PHASE2
-
An Open-Label, Staggered Rising Dose Cohort Study Assessing the Pharmacokinetics, Safety, and Tolerance of BI-RG-587 in Combination With Zidovudine in Patients With HIV Infection (CD4+ Cell Count < 400/mm3)
NCT00000649 ·Status: COMPLETED ·Phase: PHASE1
-
Safety and Efficacy of Dolutegravir/Lamivudine (DTG/3TC) in Therapy-naive Human Immunodeficiency Virus-1 (HIV-1) Infected Adolescents
NCT03682848 ·Status: COMPLETED ·Phase: PHASE3
-
A Study Comparing The Safety, Tolerability and Efficacy of Trizivir VS Combivir & Atazanavir In Subjects With HIV
NCT00082394 ·Status: COMPLETED ·Phase: PHASE4
-
Switch From Etravirine to Doravirine as a Part of Antiretroviral Combination
NCT06155019 ·Status: COMPLETED
-
A Study of 141W94 Used Alone or in Combination With Zidovudine Plus 3TC in HIV-Infected Patients
NCT00001085 ·Status: COMPLETED ·Phase: PHASE2