MedDataX Logo

Cost-effectiveness of Different Antiretroviral Treatment in Patients HIV Naive

NCT ID: NCT02470650

Last Updated: 2025-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2017-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The main objective of this study is to know the efficiency (costeffectiveness) at 48 weeks of initiation of antiretroviral treatment. three strategies of treatment.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Treatment Simplification by Darunavir/Ritonavir 800/100 mg Once a Day Versus a Triple Combination Therapy With Darunavir/Ritonavir

NCT00458302

HIV Infections AIDS Virus Human Immunodeficiency Virus +1 more
COMPLETED PHASE3

Early Access to Low-dose Ritonavir (TMC114/r) and Other Antiretrovirals (ARVs) for Treatment-naive or Early Treatment Experienced in HIV-1 Patients

NCT01702090

HIV-1
COMPLETED PHASE4

Study to Evaluate Darunavir/Ritonavir + Lamivudine Versus Continuing With Darunavir/Ritonavir + Tenofovir/Emtricitabine or Abacavir/Lamivudine in HIV Infected Subject

NCT02159599

HIV Infection
COMPLETED PHASE4

A Study to Evaluate Antiviral Activity of Darunavir + Ritonavir in HIV-1 Infected Adolescents

NCT00915655

HIV-1 Infection
COMPLETED PHASE2

Effectiveness of ABT-378/Ritonavir Plus Lamivudine Plus Efavirenz Plus Tenofovir DF in HIV-Infected Patients

NCT00038220

HIV Infections
COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Secondary objectives:

* patients with virologic response ratio at 48 weeks (less than 50 plasma viral load)
* Change in the number of CD4 cells at 48 weeks
* Change in body composition and mineral density bone (body and lumbar) measurement with DEXA (bone mineral density scan) at 48 weeks
* Change in markers of renal function (creatinine clearance, glomerular filtration rate - eGFR - estimated rate) and renal tubular function at 48 weeks
* Rate of mortality and clinical progression at 48 weeks
* general tolerability and safety: adverse events (AA) and serious AA description

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Patient Compliance Antiretroviral Therapy Intolerance

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

elvitegravir/cobicistat/emtricitabine/tenofovir

EVG / COBI / FTC / TDF (Stribild®) 150 elvitegravir, 150 cobicistat, 200 emtricitabine, 245 tenofovir disoproxil. 1 recovered tablet once a day (on a day)

Group Type EXPERIMENTAL

elvitegravir/cobicistat/emtricitabine/tenofovir

Intervention Type DRUG

1 recovered tablet once Per day ● Specify total dose (number and unit): 150 mg de elvitegravir, 150 mg cobicistat, 200 mg emtricitabine , 245 mg tenofovir disoprox milligram(s)

darunavir+ritonavir+lamivudine

Darunavir 800 mg (Prezista®) 1 recovered tablet once a day Ritonavir 100 mg(Norvir® ) 1recovered tablet once a day lamivudine300 mg (Epivir®) 1 recovered tablet once a day

Group Type ACTIVE_COMPARATOR

Darunavir

Intervention Type DRUG

Darunavir 800 mg (Prezista®) 1 recovered tablet 800 mg once a day

Ritonavir

Intervention Type DRUG

Ritonavir 100 mg recovered tablet once a day

Lamivudine

Intervention Type DRUG

lamivudine 300mg (Epivir) 1 recovered tablet

abacavir/lamivudine+rilpivirine

Abacavir 600 mg +lamivudine 300mg (Kivexa®) 1tablet once a day rilpivirine (Edurant®) 1 recovered tablet 25 mg. once a day

Group Type ACTIVE_COMPARATOR

abacavir/lamivudine

Intervention Type DRUG

Abacavir 600 mg /lamivudine 300 mg recovered tablet once a day

rilpivirine

Intervention Type DRUG

rilpivirine (Edurant®) 1 recovered tablet 25 mg. once a day

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

elvitegravir/cobicistat/emtricitabine/tenofovir

1 recovered tablet once Per day ● Specify total dose (number and unit): 150 mg de elvitegravir, 150 mg cobicistat, 200 mg emtricitabine , 245 mg tenofovir disoprox milligram(s)

Intervention Type DRUG

Darunavir

Darunavir 800 mg (Prezista®) 1 recovered tablet 800 mg once a day

Intervention Type DRUG

abacavir/lamivudine

Abacavir 600 mg /lamivudine 300 mg recovered tablet once a day

Intervention Type DRUG

Ritonavir

Ritonavir 100 mg recovered tablet once a day

Intervention Type DRUG

Lamivudine

lamivudine 300mg (Epivir) 1 recovered tablet

Intervention Type DRUG

rilpivirine

rilpivirine (Edurant®) 1 recovered tablet 25 mg. once a day

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Stribild prezista Kivexa Norvir Epivir Edurant

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 1-negative pregnancy test in women of childbearing age
* 2- stable HIV-1 infection clinically and not take antiretroviral therapy
* 3- viral load HIV \<100,000 copies
* 4- CD4 cells \>100 cels/mm3
* 5- Glomerular filtration \>70mlmin
* 6- have a negative HLA B5701
* 7-.patients should have given informed written consent
* 8- in the opinion of the investigator, be able to follow the design of the Protocol visits

Exclusion Criteria

* 1-. Patients who had virologic failure with any antiretroviral therapy
* 2- evidence of prior mutations of the study drugs
* 3- use of any anti-retroviral treatment in the 6 months prior to the entry of the study
* 4- contraindication to the drugs study
* 5- any condition that does not allow to ensure the correct compliance to the study
* 6- uncontrolled previous psychiatric illness
* 7- Current or active addiction or alcoholism
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Juan A. Arnaiz

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Juan A. Arnaiz

Josep Mallolas, Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mallolas

Role: PRINCIPAL_INVESTIGATOR

Hospital Clínic

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2014-004820-24

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

Cost-Effect-Clinic

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

TMC114-TiDP29-C232 - Study Providing Continued Access to Treatment With Darunavir (DRV)/Ritonavir (Rtv) for Children Coming From Any of the Three Ongoing Tibotec Sponsored Pediatric Studies With DRV
NCT01138605 COMPLETED PHASE2
A Clinical Trial Comparing the Efficacy of Darunavir/Ritonavir Monotherapy Versus a Triple Combination Therapy Containing Darunavir/Ritonavir and 2 Nucleoside/Nucleotide Reverse Transcriptase Inhibitors in Patients With Undetectable Plasma HIV-1 RNA on Current Treatment
NCT01448707 COMPLETED PHASE3
Safety & Efficacy of Dual Therapy With Raltegravir/Lamivudine
NCT02284035 COMPLETED PHASE3
Efavirenz or Atazanavir/Ritonavir Given With Emtricitabine/Tenofovir Disoproxil Fumarate or Abacavir/Lamivudine in HIV Infected Treatment-Naive Adults
NCT00118898 COMPLETED PHASE3
A Study to Compare Effectiveness and Safety of Darunavir/Ritonavir (DRV/Rtv) 800mg/100mg Once Daily Versus DRV/Rtv 600mg/100mg Twice Daily in Early Treatment-Experienced HIV-1 Infected Patients (ODIN)
NCT00524368 COMPLETED PHASE3
Safety, Tolerability, Drug Interactions, and Antiviral Activity of Rilpivirine in Antiretroviral-Naive HIV-Infected Children Less Than 12 Years of Age
NCT01975012 WITHDRAWN PHASE1/PHASE2
Raltegravir + Lopinavir/Ritonavir Versus Efavirenz + Tenofovir + Emtricitabine in Treatment Naive Patients
NCT00752856 COMPLETED PHASE2
Efficacy of Simplified Two Drug Kaletra Regimen vs. Kaletra Triple Drug Standard of Care Regimen in Treatment naïve HIV Infected Patients
NCT00234910 COMPLETED PHASE3
A Prospective, Open-label Trial of Two ABC/3TC Based Regimens in Late Presenter naïve Patients (CD4 <200 Cells/µL)
NCT01900106 COMPLETED PHASE3
The Effectiveness of Dual Therapy (Lopinavir/Ritonavir + LamivudinE) in Treatment-Experienced HIV Infected Patients in the Russian Federation
NCT02581202 COMPLETED
TMC114-C202: A Study of Safety, Efficacy, and Tolerability of TMC114 and Low Dose Ritonavir in HIV-1 Infected Patients
NCT00071097 COMPLETED PHASE2
Study to Evaluate the Activity and Tolerability of Lopinavir/Ritonavir and Lamivudine Bitherapy in HIV Patients With Viral Suppression
NCT01471821 COMPLETED PHASE4
Clinical Trial to Assess the Efficacy of Darunavir/Ritonavir (DRV/r), Etravirine (ETV) and Raltegravir (MK-0518) in HIV Patients With Resistant Viruses
NCT00460382 COMPLETED PHASE2
Effectiveness and Safety of Darunavir/Cobicistat Plus Lamivudine Versus Darunavir/Cobicistat Plus Tenofovir/Emtricitabine in Virologically Suppressed HIV-1-positive Individuals in Mexico
NCT06907056 RECRUITING PHASE4
TMC114IFD3001 - Study Providing Continued Access to Treatment With Darunavir (DRV)/Ritonavir(Rtv) in HIV1 Infected Adults, Adolescents and Children Aged 3 Years or Above and Coming From Previous Company Sponsored Studies With DRV
NCT01281813 COMPLETED PHASE3
Efficacy Study of Substitution of Darunavir/Ritonavir (DRV/r) for Dual-boosted Protease Inhibitors
NCT00543101 COMPLETED PHASE4
A Randomised Trial to Evaluate the Antiviral Efficacy and Safety of Treatment With 500 mg Tipranavir (TPV) Plus 100 mg or 200 mg Ritonavir (RTV) p.o. BID in Comparison to 400 mg Lopinavir (LPV) Plus 100 mg RTV p.o. BID in Combination With Standard Background Regimen in ARV Therapy naïve Patients.
NCT00144105 TERMINATED PHASE2
Open-Label Study Comparing Efficacy and Safety of ATV/RTV+3TC With ATV/RTV+TDF/FTC in HIV-Infected, Treatment Naïve Subjects, Followed by Treatment With ATV/RTV+3TC
NCT01620944 TERMINATED PHASE3
Comparison of Treatment Simplification by LPV/r vs Current Treatment Continuation in HIV-Infected Patients
NCT00140751 COMPLETED PHASE3
Raltegravir + Lopinavir/Ritonavir or Emtricitabine/Tenofovir for HIV Treatment Naive Subjects
NCT00654147 COMPLETED PHASE2
Study of Lopinavir/ Ritonavir and Lamivudine Versus Standard Therapy in Naïve HIV-1 Infected Subjects.
NCT01237444 COMPLETED PHASE3
Comparing the Effectiveness Between Ritonavir Boosted Atazanavir and Efavirenz for the First HIV Treatment
NCT00280969 COMPLETED PHASE3
Switch From Nevirapine-based Regimen to Once a Day Rilpivirine/Emtricitabine/Tenofovir
NCT02104700 COMPLETED PHASE2/PHASE3
A Study of ABT-378/Ritonavir Combination in HIV-Infected Patients Who Have Taken Protease Inhibitors
NCT00004580 COMPLETED PHASE1
DRV/r + RPV QD: Efficacy and Toxicity Reduction
NCT01792570 COMPLETED PHASE3