AzTrials
AzTrials

HIV-1 InfectionPhase 4ANDESNCT02770508

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

A Phase 4 study testing darunavir/ritonavir, Lamivudine and emtricitabine-tenofovir(FTC/TDF) in people with HIV-1 Infection, run by Fundación Huésped at 5 sites in Argentina.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV-1 Infection
What is being tested?
darunavir/ritonavir, Lamivudine and emtricitabine-tenofovir(FTC/TDF)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
145 participants
Where
5 sitesArgentina
Study dates
Nov 2015to Oct 2017
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • > 18 years of age.
  • 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.
  • 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.
  • 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.
  • Documented HIV-1 RNA >1,000 copies/mL
  • Subject naïve to ARV. (Patients who had received ARV ≤ 48 hours are allowed). Subject has indication to receive an antiretroviral regimen.
Show all 13Show fewer
  • Subjects can comply with protocol requirements.
  • Subject's general medical condition, in the investigator's opinion, does not interfere with assessments and completion of the trial.
  • 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
  • has a urine pregnancy test performed at the Screening Visit and on Baseline. Results of both tests must be negative.
  • continue using 2 different methods of birth control including, at least, one barrier method for at least 30 days after the end of the treatment period
  • For male patients, must comply with the use of a barrier birth control method during the Study and 60 days beyond the Study completion

Who cannot join

  • 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.
  • Prior HIV-2 documented infection.
Show all 20Show fewer
  • The use of disallowed concomitant therapy (see Appendix C).
  • Active Hepatitis B infection (at any stage).
  • 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.
  • 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.
  • The patient has an active AIDS-associated opportunistic disease (Category C according to the CDC classification system for HIV infection as of 1993) within 30 days after the screening. Stabilized patients under treatment for AIDS-associated opportunistic disease may be included in the study.
  • Life expectancy < 1 year according to the investigator
  • Laboratory tests performed during the screening visit show any of the following alterations:
  • Hemoglobin <8.0 gm/dL
  • Absolute neutrophil count (ANC) < 750 cells/µL
  • Platelet Count < 50,000 cells/mm3
  • The use of any study agent within 30 days as from the screening.
  • Use of immunosuppressive drugs, cytokines inhibitors or other cytokines over the prior year.
  • Any other condition (including, without limitation, the use of alcohol or drugs) that in the investigator's opinion may compromise the safety of the patient or his/her adherence to the protocol
  • Patients who are pregnant or breastfeeding

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Argentina5 sites

  • Consultorio Infectológico Dr. Pryluka

    CABA, Buenos Aires, 1121

  • Hospital Cosme Argerich

    CABA, Buenos Aires, 1155ADP

  • Hospital Italiano

    CABA, Buenos Aires, 1199ABB

  • Fundacion huesped

    CABA, Buenos Aires, C1202ABB

  • Centro de Estudios Infectologicos SA (CTD Stamboulian)

    CABA, Buenos Aires, C1425AWK

Other trials in Argentina

About this study

Official title: 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

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.

Read the 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)
Conditions
HIV-1 Infection
Being tested
darunavir/ritonavir, Lamivudine, emtricitabine-tenofovir(FTC/TDF)
Keywords
antiretroviral naive, dual therapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • darunavir/ritonavirDrug

    Also called Virontar R

  • LamivudineDrug

    Also called 3TC

  • emtricitabine-tenofovir(FTC/TDF)Drug

    Also called TRUVADA

Study groups in NCT02770508
Study groupRoleWhat they receive
Darunavir/ritonavir plus lamivudineExperimentalDarunavir/ritonavir 800/100 mg, 1 coformulated tablet QD and lamivudine 300 mg, 1 tablet QD
Receives: Drug: darunavir/ritonavir; Drug: Lamivudine
Darunavir/ritonavir plus emtricitabine/tenofovir(FTC/TFD)Active comparatorDarunavir/ritonavir 800/100 mg1 coformulated tablet QD (FDC) plus FTC/TDF 200/300 mg, 1 coformulated tablet QD
Receives: Drug: darunavir/ritonavir; Drug: emtricitabine-tenofovir(FTC/TDF)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of patients with HIV-1 RNA levels of less than 50 copies/mL at week 48

    The percentage of participants with Plasma Human Immunodeficiency Virus-1 (HIV-1) <50 c/mL at Week 48 will be assessed using Missing, Switch or Discontinuation = Failure (MSDF), as codified by the Food and Drug Administration (FDA) "snapshot" algorithm. This algorithm treated all participants without HIV-1 RNA data at Week 48 as nonresponders, Otherwise, virologic success or failure will be determined by the last available HIV-1 RNA assessment while the participant was on-treatment in the snapshot window (Week 48 +/- 6 weeks).

    Measured: 48 weeks

Secondary outcomes (6)

  1. Percentage of patients with HIV-1 RNA <400 copies/mL at week 24

    The percentage of participants with Plasma Human Immunodeficiency Virus-1 (HIV-1) <400 c/mL at Week 24 will be assessed using Missing, Switch or Discontinuation = Failure (MSDF), as codified by the Food and Drug Administration (FDA) "snapshot" algorithm.

    Measured: 24 weeks

  2. Number and type of resistance mutations in case of virologic failure

    An genotiping test will be made at time to virological failure to detect mutation across reverse transcriptase (RT), and Protease (PRO). Protocol defined virological failure was defined as confirmed plasma HIV-1 RNA levels >=400 copies/mL on or after Week 24 or confirmed plasma HIV-1 RNA levels >=50 copies/mL at week 48

    Measured: from week 24 to week 48

  3. CD4+ lymphocyte count and change between baseline (defined as the average between screening and baseline visit values) and weeks 24 and 48

    Change from Baseline in CD4+ cell counts will be assessed at Weeks 24 and 48.

    Measured: week 24 and 48

  4. Frequency, type and severity of adverse events and laboratory abnormalities.

    Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment

    Measured: week 24 and 48

  5. Clinical disease progression (CDP)

    Clinical disease progression (CDP) was assessed according to the Centers for Disease Control and Prevention (CDC) HIV-1 classification system. Category (CAT) A: one or more of the following conditions (CON), without any CON listed in Categories B and C: asymptomatic HIV infection, persistent generalized lymphadenopathy, acute (primary) HIV infection with accompanying illness or history of acute HIV infection. CAT B: symptomatic CON that are attributed to HIV infection or are indicative of a defect in cell-mediated immunity; or that are considered by physicians to have a clinical course or to require management that is complicated by HIV infection; and not included among CON listed in clinical CAT C. CAT C: the clinical CON listed in the AIDS surveillance case definition. Indicators of CDP were defined as: CDC CAT A at Baseline (BS) to a CDC CAT C event (EV); CDC CAT B at BS to a CDC CAT C EV; CDC CAT C at BS to a new CDC CAT C EV; or CDC CAT A, B, or C at BS to death.

    Measured: week 24 and 48

  6. Changes in quality of life

    The evaluation of quality of life will be done through two validated instruments: the Medical Outcomes Study HIV Health Survey ( MOS - HIV) and EuroQol 5D (EQ - 5D ) . Both instruments will be administered to patients at baseline , week 24 and week 48 .

    Measured: baseline, week 24 and week 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 May 2016 (estimated)
  2. Study startNov 2015
  3. Primary completionJul 2017
  4. Study completionOct 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
145 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02770508
Sponsor's protocol ID
FH-15
Acronym
ANDES
Status last verified
Aug 2018
First submitted
16 Nov 2015
Last updated
3 Aug 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes: To publish week 48 study

Publications

  • Figueroa MI, Sued O, Cecchini D, Sanchez M, Rolon MJ, Lopardo G, Ceschel M, Mernies G, De Stefano M, Patterson P, Gun A, Fink V, Ortiz Z, Cahn P; ANDES Study Group. Dual therapy based on co-formulated darunavir/ritonavir plus lamivudine for initial therapy of HIV infection: The ANDES randomized controlled trial. Int J Antimicrob Agents. 2024 Oct;64(4):107301. doi: 10.1016/j.ijantimicag.2024.107301. Epub 2024 Aug 14.

    PubMed 39151647

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing darunavir/ritonavir, Lamivudine and emtricitabine-tenofovir(FTC/TDF) in people with HIV-1 Infection, run by Fundación Huésped at 5 sites in Argentina.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of patients with HIV-1 RNA levels of less than 50 copies/mL at week 48 (time frame: 48 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02770508, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in