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HIV II InfectionPhase 2NCT03224338

Dolutegravir Plus 2 NRTIs, in Treatment-Naïve HIV-2 Infected Subjects

A Phase 2 study testing Dolutegravir 50 mg in people with HIV II Infection, run by Blueclinical, Ltd. at 6 sites in Portugal.

Completed

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

Official record
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Trial summary

Multicenter, single-arm, open-label clinical trial to evaluate the efficacy, the safety and the tolerability of 50 mg dolutegravir once daily (q.d.) given in combination with 2 NRTIs backbone in HIV-2 positive, treatment-naïve subjects. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV II Infection
What is being tested?
Dolutegravir 50 mg
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
6 sitesPortugal
Study dates
5 Apr 2017to 2 Jul 2019
Phase
Phase 2
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

  • A subject is eligible for the study if he/she fulfills all of the following inclusion criteria:
  • Able to understand and willing to comply with all the requirements of the study, as confirmed by giving voluntary written informed consent for participation.
  • Male or female gender.
  • Age ≥ 18 years on the day of signing the informed consent.
  • HIV-2 positive as determined by a positive result in the respective assay.
  • CD4 count ≤500 cells/mm3 (in case of undetectable baseline HIV-2 viral load); and/or classified as B- or C-stage, by the HIV disease staging and classification system of Centers for Disease Control and Prevention (CDC); and/or have detectable viral load irrespective of CD4 count; and/or have other medical conditions / co-morbidities in which treatment is considered, according to European AIDS Clinical Society (EACS) and national guidelines;
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  • Naïve to ART including investigational antiretroviral agents .
  • Considered clinically stable with no signs or symptoms of active infection, at the time of entry into the study (i.e., clinical status and all chronic medications should be unchanged for at least 2 weeks prior to the start of treatment in this study), in the opinion of the investigator.
  • If woman or man with reproductive potential, agrees to adopt one of the following effective contraceptive methods throughout the study:
  • True abstinence, if this is in line with the preferred and usual lifestyle of the subject [Period abstinence (e.g., abstinence only on certain calendar days, abstinence only during ovulation period, use of symptothermal method, use of post-ovulation methods) and withdrawal are not acceptable methods of contraception].
  • Use of an acceptable method of birth control throughout the study (either by subject or subject's partner). Acceptable methods of birth control are: oral contraceptive, intrauterine device (IUD), diaphragm with spermicide, contraceptive sponge, condom, vasectomy. All forms of hormonal contraception are acceptable. However, the investigator should consult local prescribing information for guidance on the use of hormonal contraceptives with background ART as some antiretrovirals have clinically significant drug interactions with these products.
  • NOTE: A subject who is not of reproductive potential , is not sexually active, whose current partner(s) is/are not of reproductive potential, or whose sexual activity is exclusively homosexual is eligible without requiring the use of contraception. However, use of barrier methods of contraception is strongly encouraged to reduce the risk of HIV-2 transmission during sexual contact.

Who cannot join

  • A subject is not eligible for the trial if he/she fulfills any of the following exclusion criteria:
  • History or presence of allergy to the study drugs or their components.
  • HIV-1 infection or HIV-1/HIV-2 dual infection.
  • History or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the subject's participation for the full duration of the study, such that it is not in the best interest of the subject to participate.
  • Documented or known resistance to DTG and/or NRTIs.
  • Treatment with systemic immunosuppressive therapy or immune modulators within 30 days prior to treatment in this study or is anticipated to need them during the course of the study.
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  • NOTE: "Short courses" of corticosteroids (e.g., as for asthma exacerbation) will be allowed. "Short courses" mean a use of corticosteroids for less than 7 days.
  • Requiring or is anticipated to require any of the prohibited medications while in the study (dofetilide, inducers of CYP3A4, including phenobarbital, phenytoin, carbamazepine and rifampicin).
  • NOTE: Subjects must discontinue phenobarbital, phenytoin, carbamazepine, and rifampicin at least 14 days prior to the treatment phase of the study.
  • Current (active) diagnosis of tuberculosis.
  • Alanine aminotransferase (ALT) ≥5 times the upper limit of normal (ULN), or ALT ≥3xULN and bilirubin ≥1.5xULN (with >35% direct bilirubin).
  • Moderate to severe hepatic impairment (Class B or greater) as determined by Child-Pugh classification .
  • If subject eligible to receive Tivicay®: Unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice), cirrhosis, known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
  • Estimated creatinine clearance <50 mL/min at time of screening, based on Cockcroft-Gault equation .
  • Current (active) diagnosis of acute hepatitis due to any cause. NOTE: Subjects with chronic hepatitis B and C may enter the study as long as they fulfil all entry criteria, have stable liver function tests, and have no significant impairment of hepatic synthetic function (significant impairment of hepatic synthetic function is defined as a serum albumin <2.8 g/dL in the absence of another explanation for the abnormal laboratory value) at the time of enrollment.
  • Under treatment for a viral infection other than HIV-2, such as hepatitis B, with an agent that may be active against HIV-2, including but not limited to 3TC, TDF or entecavir, unless the treatment with these agents occurred prior to the diagnosis of HIV.
  • Anticipated need for Hepatitis C virus (HCV) therapy with interferon and/or ribavirin during the study.
  • Positive HLA-B*5701 allele screening assessment and is also not eligible for treatment with the other acceptable NRTIs (TDF/FTC).
  • Significant suicidality risk, according to the investigator's judgment. NOTE: Recent history of suicidal behavior and/or suicidal ideation may be considered as evidence of serious suicide risk.
  • Participation in a study with an investigational compound/device within 30 days of signing informed consent or anticipates participating in such a study involving an investigational compound/device during the course of this study.
  • If woman, she is pregnant, breastfeeding, or expecting to conceive at any time during the study.
  • If woman, she is expecting to donate eggs at any time during the study.
  • If man, expecting to donate sperm at any time during the study.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Portugal6 sites

  • Centro Hospitalar de Lisboa Central Hospital Curry Cabral

    Lisbon

  • Centro Hospitalar de Lisboa Ocidental Hospital de Egas Moniz

    Lisbon

  • Centro Hospitalar Lisboa Norte Hospital de Santa Maria

    Lisbon

  • Hospital Beatriz Ângelo Loures

    Lisbon

  • Hospital Garcia de Orta

    Lisbon

  • Hospital Professor Doutor Fernando Fonseca Amadora

    Lisbon

Other trials in Portugal

About this study

Official title: A Phase II, Multicenter, Single-Arm, Open-Label Clinical Trial to Evaluate the Safety and Efficacy of Triple Therapy With Dolutegravir Plus 2 NRTIs, in Treatment-Naïve HIV-2 Infected Subjects

Multicenter, single-arm, open-label clinical trial to evaluate the efficacy, the safety and the tolerability of 50 mg dolutegravir once daily (q.d.) given in combination with 2 NRTIs backbone in HIV-2 positive, treatment-naïve subjects.

Read the detailed description

Subjects who fulfill all inclusion criteria and none of the exclusion criteria, after giving informed consent, will be eligible for participation in this study. At the Visit 2 (Day1) subjects will receive the study medication and instructions for its administration. Thereafter, subjects will return to the investigational site at week 4, 12, 24, 36 and 48, for efficacy and safety assessments.

Subjects who meet the virologic failure criteria will return to the investigational site approximately one week later to repeat viral RNA testing (Virologic Failure Confirmation visit). If virologic failure is confirmed and the viral load meets the criteria for resistance testing, viral resistance testing will then be performed.

Being tested
Dolutegravir 50 mg

What participants receive

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

  • Dolutegravir 50 mgDrug

    Dolutegravir will be used in combination with 2 nucleoside reverse transcriptase inhibitors (NRTIs). The NRTIs used in combination with DTG will be abacavir (ABC) plus lamivudine (3TC) or tenofovir (TDF) plus emtricitabine (FTC), which is in line with the current standard of care. The combination ABC/3TC/DTG will be preferential except in case of hepatitis B co-infection or in case the subject has a positive HLA-B*5701 allele screening assessment.

Study groups in NCT03224338
Study groupRoleWhat they receive
: Dolutegravir (DTG)ExperimentalNot described
Receives: Drug: Dolutegravir 50 mg

What is being measured

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

  1. Efficacy analysis- treatment efficacy, as measured by the "overall treatment success defined as proportion of patients with "global success" at week 48.

    The primary objective of this study is to evaluate the efficacy of DTG in combination with two NRTIs [ABC/3TC or TDF/FTC] in the treatment of HIV-2 treatment-naïve subjects, as measured by the proportion of subjects achieving a plasma viral load of <40 copies/mL and/or by the change from baseline in CD4 cell count and in CD4/CD8 ratio at Week 48. Global success" is a composite variable defined as a plasma HIV-2 RNA viral load <40 copies/mL and a delta of CD4 depending on the initial CD4 count (CD4 delta >+100 cells/mm3 for initial CD4s ≤ 500 cells/mm3; or CD4delta > +50 cells/mm3 for initial CD4s > 500 cells/mm3).

    Measured: 48 Weeks

Secondary outcomes (3)

  1. Study treatment immunological effect

    To evaluate the study treatment immunological effect, as measured by the change from baseline in CD4 cell count and the CD4/CD8 ratio at Week 48.

    as measured by the change from baseline in CD4 cell count and the CD4/CD8 ratio at Week 48. Change from Baseline in CD4 Cell Count and CD4/CD8 ratio Change from baseline in CD4 cell count and the CD4/CD8 ratio will be estimated at each time point with CD4 and CD8 cell count collection with a key interest at Week 12, 24 and 48.

    Measured: 12, 24 and 48 Weeks

  2. Study treatment immunological effect

    Proportions of subjects achieving HIV-2 RNA < 40 copies/mL. The proportions of subjects achieving HIV-2 RNA <40 copies/mL will be estimated at Week 12, 24 and 48.

    Measured: 12, 24 and 48 Weeks

  3. Safety and tolerability of the study treatment, as assessed by review of the accumulated safety data.

    The following clinical and laboratory adverse experiences will be summarized:

    Subjects with at least one adverse experience. Subjects with at least one drug related adverse experience. Subjects with at least one serious adverse experience. Subjects with at least one serious and drug related adverse experience, Subjects who discontinued study therapy due to an adverse experience.

    Measured: 24 weeks or rebounder at least one week apart afte rinitial response

Timeline

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

  1. First posted21 Jul 2017
  2. Study start5 Apr 2017
  3. Primary completion2 Jul 2019
  4. Study completion2 Jul 2019

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03224338
Sponsor's protocol ID
DTG-01-01
Status last verified
Aug 2019
First submitted
6 Jun 2017
Last updated
3 Sep 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Pacheco P, Marques N, Rodrigues P, Mansinho K, Maltez F, Janeiro N, Franco C, Trigo D, Batista J, Duque L, Lopes MJ, Aleixo MJ, Silva AR, Tavares R, Alves J, Peres S, Povoas D, Lino S, Gomes P, Araujo V, Lopes C. Safety and Efficacy of Triple Therapy With Dolutegravir Plus 2 Nucleoside Reverse Transcriptase Inhibitors in Treatment-Naive Human Immunodeficiency Virus Type 2 Patients: Results From a 48-Week Phase 2 Study. Clin Infect Dis. 2023 Sep 11;77(5):740-748. doi: 10.1093/cid/ciad339.

    PubMed 37288954

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dolutegravir 50 mg in people with HIV II Infection, run by Blueclinical, Ltd. at 6 sites in Portugal.

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 23 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 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Portugal. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Efficacy analysis- treatment efficacy, as measured by the "overall treatment success defined as proportion of patients with "global success" 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 NCT03224338, 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 Sep 2019; AzTrials last refreshed its copy on 7 Nov 2026.

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