AzTrials
AzTrials

Chronic Infection With HIVPhase 4ARTENCT01829802

RAL+ATV/r in Comparison With TDF/FTC (or 3TC) +ATV/r in HIV Infected Patients

A Phase 4 study testing Ritonavir boosted Atazanavir, Raltegravir and TDF/FTC (or 3TC) in people with Chronic Infection With HIV, run by Pedro Cahn at 2 sites in Argentina.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

The purpose of this pilot study is to assess the efficacy and safety of the combination of RAL+ATV/r in comparison with TDF/FTC+ATV/r in HIV-1 infected patients presenting virologic failure and PI and TDF naïve. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Infection With HIV
What is being tested?
Ritonavir boosted Atazanavir, Raltegravir and TDF/FTC (or 3TC)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
2 sitesArgentina
Study dates
May 2014to 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

  • Male or female subject ≥18 years of age.
  • Documented HIV-1 infection defined as a positive ELISA plus a confirmatory Western Blot; or a plasma HIV-1 RNA ≥10,000 copies/mL ever documented.
  • Patients who have failed their initial treatment containing NNRTI(s) + 2NRTI(s) combination therapy, according to virological criteria defined by two consecutive (at least 7 days apart) HIV-1 RNA results ≥500 copies/mL. Subject must be on stable HAART for at least the last 4 weeks.
  • No prior or current exposure to HIV-1 protease inhibitors and/or HIV-1 integrase inhibitors.
  • Subject must have susceptibility to ATV/r and TDF, as resulted by resistance testing at screening. RAL sensitivity is not required for patients never exposed to this drug in the country.
  • Subject has voluntarily signed ICF.
Show all 12Show fewer
  • Subject 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.
  • 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.
  • If female, is not breastfeeding or pregnant.
  • If female, subject 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, that are acceptable to both the subject and investigator, and willing to continue their use for at least 30 days after the end of the treatment period.
  • Subjects must have a life-expectancy of more than 1 year.

Who cannot join

  • Patient has a current (active) diagnosis of acute hepatitis due to any cause OR chronic hepatitis B and/or C WITH aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >2.5 x upper limit of normal (ULN) AND/OR is likely to require hepatitis treatment in the next year.
  • Active hepatitis B infection (positive HBsAg), regardless of stage of infection.
  • Subject has a currently active AIDS defining illness (Category C conditions according to the CDC Classification System for HIV infection 1993) in the last 30 days.
  • Subjects with a laboratory abnormality Grade 3 or 4 with the following exceptions: pancreatic amylase, cholesterol, triglycerides, gamma glutamyl transpeptidase.
  • Screening laboratory analysis show any of the following abnormal results:
  • Hemoglobin <8.0 g/dL
Show all 13Show fewer
  • Absolute neutrophil count <750 cells/µL
  • Platelet count <50,000 mm3
  • Creatinine >1.5 x ULN
  • Any condition that, in the investigators opinion, could compromise the subject's safety or adherence to the trial protocol.
  • The use of any study agent within 30 days prior to screening.
  • Use of immunosuppressive drugs, cytokines inhibitors or other cytokines in the previous 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.

Trial locations and contacts

2 sites in 1 country.

Argentina2 sites

  • Fundacion Huesped

    Buenos Aires, Buenos Aires, C1202ABB

  • Dra Luna Norma

    Córdoba, Córdoba Province, 5000

Other trials in Argentina

About this study

Official title: A Pilot Randomized, Open Label Study to Evaluate Efficacy and Safety of the Combination of RAL+ATV/r in Comparison With TDF/FTC+ATV/r in HIV Infected Patients, Who Failed an Initial NNRTI Containing Regimen

The purpose of this pilot study is to assess the efficacy and safety of the combination of RAL+ATV/r in comparison with TDF/FTC+ATV/r in HIV-1 infected patients presenting virologic failure and PI and TDF naïve.

Read the detailed description

Overall Study Design and Plan: Description

This is a pilot, randomized, open-label study. All the participants will be assigned to receive RAL+ATV/r or TDF/FTC+ATV/r. Patients will be evaluated at screening, randomization (day 0), and on weeks 4, 8, 12, 24, 36 and 48.

At the screening visit, subjects must be willing and able to give written (signed and dated) informed consent prior to any study specific procedures. They will receive a unique screening number and will undergo the study procedures associated with the screening visit. The investigator will evaluate whether the subject meets all eligibility criteria specified and record the details of the informed consent process and the results of this assessment in the subject's medical records. Two forms of the ICF will be signed, one for the subject and the other to file at the site.

At baseline visit, enrollment criteria will be reviewed and subjects who meet all of them will undergo study procedures. Subjects will receive instructions about study medications and dosing schedule. Subjects should start study medication within 24 hours of the baseline visit. Subjects will return to the investigator´s site for study visits and procedures. Subjects who prematurely discontinue the study must return for a discontinuation visit and undergo the study procedures identified for the discontinuation visit.

Being tested
Ritonavir boosted Atazanavir, Raltegravir, TDF/FTC (or 3TC)
Keywords
HIV, Raltegravir, Boosted atazanavir

What participants receive

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

  • Ritonavir boosted AtazanavirDrug

    Also called Reyataz, Norvir

    Ritonavir boosted Atazanavir 300/100 mg QD in combination with other drugs

  • RaltegravirDrug

    Also called Isentress

    Raltegravir 400 BID in combination with Ritonavir boosted Atazanavir 300/100 mg QD during 48 weeks

  • TDF/FTC (or 3TC)Drug

    Also called Truvada, TDF-FTC, TDF-3TC, Mivuten

    Fixed dose combination of Tenofovir 300 mg/Emtricitabine 200 mg or Tenofovir 300 mg/Lamivudine 300 mg plus Ritonavir Boosted Atazanavir 300/100mg given once a day

Study groups in NCT01829802
Study groupRoleWhat they receive
RAL+ATA/rExperimentalRaltegravir 400 mg BID plus Ritonavir Boosted Atazanavir 300/100 mg QD
Receives: Drug: Ritonavir boosted Atazanavir; Drug: Raltegravir
TDF/FTC (or 3TC) +ATA/rActive comparatorTDF/FTC (or 3TC)- Fixed dose combination of Tenofovir 300 mg plus Emtricitabine 200 mg (or Lamivudine 300 mg) QD plus Ritonavir Boosted Atazanavir 300/100 mg QD
Receives: Drug: Ritonavir boosted Atazanavir; Drug: TDF/FTC (or 3TC)

What is being measured

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

  1. Proportion of subjects with plasma HIV-1 RNA below the limit of detection (<50 copies/mL)in an intention to treat (exposed) analysis.

    Measured: 48 weeks

  2. Proportion of subjects with SAEs and proportion with AEs leading to discontinuation.

    Measured: Through week 48

Secondary outcomes (3)

  1. Change from baseline on viral load

    Measured: 24 and 48 weeks

  2. Change from baseline in lipid profile and renal function

    Measured: Through 48 weeks

  3. Change from baseline in inflammation markers

    Measured: 24 and 48 weeks

Timeline

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

  1. First posted11 Apr 2013 (estimated)
  2. Study startMay 2014
  3. Primary completionOct 2017 (estimated)
  4. Study completionOct 2017 (estimated)

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
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01829802
Sponsor's protocol ID
FH-14
Other IDs
50250
Acronym
ARTE
Status last verified
Jan 2017
First submitted
8 Apr 2013
Last updated
24 Jan 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ritonavir boosted Atazanavir, Raltegravir and TDF/FTC (or 3TC) in people with Chronic Infection With HIV, run by Pedro Cahn at 2 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 12 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 24 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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?

Results are not available in the source record.

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?

Proportion of subjects with plasma HIV-1 RNA below the limit of detection (<50 copies/mL)in an intention to treat (exposed) analysis. (time frame: 48 weeks). The study lists 2 primary outcomes in all. 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 NCT01829802.

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 24 Jan 2017.

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