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COMPLETEDPHASE4

Darunavir/Ritonavir + Lamivudine Versus Darunavir/Ritonavir +Emtricitabine/Tenofovir in Naïve HIV-1 Infected Subjects

A Phase 4, Randomized, Open Label, Controlled Study of Boosted Darunavir and Lamivudine Versus Boosted Darunavir and Emtricitabine/Tenofovir or Lamivudine/Tenofovir in Naïve HIV-1 Infected Subjects

NCT02770508•Fundación Huésped

View on ClinicalTrials.gov

Summary

The purpose of this study is to compare the safety and efficacy of a combination of a QD regimen consisting on ritonavir boosted darunavir (FDC) and lamivudine versus ritonavir boosted darunavir (FDC) plus co-formulated tenofovir and emtricitabine or co-formulated tenofovir/lamivudine in naïve HIV-1 infected patients. Subjects will be ARV-naïve HIV-1-infected patients eligible to start ARV therapy according to current guidelines.Subjects will be adults ≥ 18 years of age who meet all of the inclusion criteria and none of the exclusion criteria.

Detailed Description

Key Inclusion Criteria 1. Documented HIV RNA \>1000 copies/ml 2. Subject naïve to ARV. . 3. Subject has indication to receive an antiretroviral regimen, based on local guidelines. 4. Able to provide informed consent and agree to use a highly effective non-hormonal method of contraception Key Exclusion Criteria 1. Evidence of resistance to Darunavir and/or FTC or 3TC or TDF based on the resistance test 2. Patient with chronic hepatitis B 3. Subject has a currently active AIDS defining illness (Category C conditions according to the CDC Classification System 4. Required use of disallowed concomitant therapies 5. Subject with the grade 3 or 4 laboratory abnormalities as defined by DAIDS grading table Primary Objective • Proportion of patients with HIV-1 RNA levels of less than 50 copies/mL at week 48 (ITT analysis, Snapshot analysis)

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. \> 18 years of age.
•2. Patient with documented HIV-1 infection defined as a positive ELISA plus a confirmatory Western Blot; or alternatively, a plasma HIV-1 RNA ≥1,000 copies/mL ever documented.
•3. Subject has voluntarily signed and dated an informed consent form, approved by an Institutional Review Board (IRB) / Independent Ethics Committee (IEC), after the nature of the study has been explained and the subject has had the opportunity to ask questions. The informed consent must be signed before any study-specific procedures are performed.
•4. Subject agrees not to take any medication during the study, including over the counter medicines or herbal preparations, without the approval of the trial physician.
•5. Documented HIV-1 RNA \>1,000 copies/mL
•6. Subject naïve to ARV. (Patients who had received ARV ≤ 48 hours are allowed). Subject has indication to receive an antiretroviral regimen.
•7. Subjects can comply with protocol requirements.
•8. Subject's general medical condition, in the investigator's opinion, does not interfere with assessments and completion of the trial.
•9. If patient is a female she must not be breastfeeding or pregnant. She must be either postmenopausal for at least one year, surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or she must:
•* use 2 different methods of birth control including, at least, one barrier method, and are acceptable to both the subject and investigator, and
+3 more criteria

Exclusion Criteria

•1. Evidence of resistance to or 3TC or DRV/r, TDF, FTC o 3TC based in the results of the resistance testing done in the screening visit, such resistance being considered in accordance with IAS-USA panel, version dated March 2013.
•Any of the following mutations will be considered resistance to DRV/r :
•* I47V, I50V, I54M/L, L76V, I84V or, 3 or more minor mutations : V11I, V32I, L33F, T74P, L89V.
•* Any of the following mutations will be considered resistance to 3TC or FTC : M184V/I and /or K65R and / or Q151M.
•* Any of the following mutations will be considered resistance to TDF: K65R, K70E, double insertion 69 or 3 TAMS including M41L or L210W.
•2. Prior HIV-2 documented infection.
•3. The use of disallowed concomitant therapy (see Appendix C).
•4. Active Hepatitis B infection (at any stage).
•5. The patient was diagnosed with acute active hepatitis by any cause, or chronic hepatitis C WITH levels of aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \> 5 higher than the upper limit of normal (ULN) AND/OR may require one-year treatment.
•6. Any clinical significant active disease (for instance, tuberculosis, heart failure, pancreatitis) or any medical history or physical examination findings that, according to the investigator's opinion, may risk the patient's safety, the results of the study or adherence to the rules of the protocol.
+10 more criteria

Locations (5)

Consultorio Infectológico Dr. Pryluka

CABA, Buenos Aires, Argentina

Hospital Cosme Argerich

CABA, Buenos Aires, Argentina

Hospital Italiano

CABA, Buenos Aires, Argentina

Fundacion huesped

CABA, Buenos Aires, Argentina

Centro de Estudios Infectologicos SA (CTD Stamboulian)

CABA, Buenos Aires, Argentina

Key Dates

Start Date

November 1, 2015

Primary Completion Date

July 1, 2017

Completion Date

October 1, 2017

Last Updated

August 3, 2018

Enrollment

145

ACTUAL participants

Conditions

HIV-1 Infection

Interventions

darunavir/ritonavir

DRUG

Lamivudine

DRUG

emtricitabine-tenofovir(FTC/TDF)

DRUG

Change in Body Weight and BMI in PWH with DOR/3TC/TDF Compared with INSTI

NCT06602622

HIVHIV Associate Weight Loss+4 more

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COMPLETEDPHASE4

Implementation of Out-of-HOspital Administration of the Long-Acting Cabotegravir+Rilpivirine

NCT06185452

HIV-1 Infection

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 3, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Darunavir/Ritonavir + Lamivudine Versus Darunavir/Ritonavir +Emtricitabine/Tenofovir in Naïve HIV-1 Infected Subjects

Inclusion Criteria

Exclusion Criteria

Change in Body Weight and BMI in PWH with DOR/3TC/TDF Compared with INSTI

Implementation of Out-of-HOspital Administration of the Long-Acting Cabotegravir+Rilpivirine

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