HIV-1 InfectionPhase 4PADDLE184VNCT05295394
Dolutegravir-Lamivudine as Dual Therapy in naïve HIV-Infected Patients With Documented M184V Mutation:A Pilot Study
A Phase 4 study testing Dolutegravir plus lamivudine in people with HIV-1 Infection, run by Pedro Cahn at 2 sites in Argentina.
Trial summary
The purpose of this study is to evaluate the antiviral efficacy, safety and tolerability of dual therapy with 3TC and DTG as initial therapy among naïve HIV patients with a documented M184V mutation. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV-1 Infection
- What is being tested?
- Dolutegravir plus lamivudine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesArgentina
- Study dates
- 22 May 2019to 30 Aug 2022
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥18 years of age.
- Documented HIV-1 infection defined as a positive rapid test or ELISA plus a plasma HIV-1 RNA ≥5,000 copies/mL or a reactive western blot.
- 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 (see Appendix 4).
- Naïve to ARV therapies (previous exposure to ARV drugs < 10 days).
- Documented M184V mutation associated with resistance to lamivudine in a previous genotypic test (last 3 months), or at screening.
- HIV RNA at screening visit ≥5,000 copies/mL and <≤100,000 copies/ml
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- CD4 ≥200 cells/mL
- Subjects can comply with protocol requirements.
- 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.
- Subject's general medical condition, in the investigator's opinion, does not interfere with assessments and completion of the study.
- The patient is a male or a female who is not breastfeeding or pregnant.
- A female may be eligible to enter and participate in the study if she:
- is of non-child-bearing potential either defined as post-menopausal (12 months of spontaneous amenorrhea and ≥ 45 years of age) or physically incapable of becoming pregnant with documented tubal ligation, hysterectomy or bilateral oophorectomy or,
- is of child-bearing potential with a negative pregnancy test at both screening and day 1, and, agrees to use one of the highly effective methods of contraception to avoid pregnancy described in Appendix 3.
Who cannot join
- Patients will NOT be selected to be part of this study if they meet ANY of the following criteria:
- Alcohol or drug use that might impact on adherence
- Subjects positive for Hepatitis B at screening (+HBsAg), or anticipated need for Hepatitis C virus (HCV) therapy during the study
- Women who are pregnant or breastfeeding, or women who plan to become pregnant in the next 2 years
- interferon, interleukin-2, cytotoxic chemotherapy, Dofetilide (or pilsicainide) or immunosuppressors, antacid drugs containing Ca++ and or Mg++ at study entry
- Grade 4 lab abnormalities
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- Primary HIV infection (indeterminate WB or previous negative HIV in the last 6 months
- Opportunistic infection (CDC C category) or other disease and/or clinical condition that, in the investigator's opinion, would compromise the patient's safety or outcome of the study; including malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or cervical intraepithelial neoplasia
- Subjects who in the investigator's judgment, poses a significant suicidality risk.
- History or presence of allergy to the study drugs or their components or drugs of their class
- Treatment with any of the following agents within 28 days of screening: radiation therapy; cytotoxic chemotherapeutic agents; any immunomodulators that alter immune responses or treatment with an HIV-1 immunotherapeutic vaccine within 90 days of screening or exposure to an experimental drug or experimental vaccine within either 28 days, 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent, whichever is longer, prior to the first dose of investigational product
- Any acute laboratory abnormality at screening, which, in the opinion of the Investigator, would preclude the subject's participation in the study of an investigational compound;
- Alanine aminotransferase (ALT) >5 times the upper limit of normal (ULN), or ALT ≥ 3xULN and bilirubin ≥ 1.5xULN (with >35% direct bilirubin)
- Creatinine clearance of <50mL/min via Cockroft-Gault method
- Subjects with moderate to severe hepatic impairment (Class B or greater) as determined by Child-Pugh classification
Trial locations and contacts
2 sites in 1 country.
Argentina2 sites
Fundacion huesped
CABA, Buenos Aires, C1202ABB
CAICI
Rosario, Santa Fe Province, S2000PBJ
About this study
The purpose of this study is to evaluate the antiviral efficacy, safety and tolerability of dual therapy with 3TC and DTG as initial therapy among naïve HIV patients with a documented M184V mutation.
Read the detailed description
This is a pilot study designed to evaluate the antiviral efficacy, safety and tolerability of dual therapy with 3TC and DTG as initial therapy among naïve HIV-1 subjects ≥ 18 years old carrying the M184V mutation
This will be evaluated as the proportion of patients with pVL < 50 copies/mL at week 48 using the ITT-exposed analysis (FDA snaphot).
This study will consist of a screening period of up to 42 days, a 48-week treatment period, followed by a 4-week post-treatment follow-up (FU) period to document late adverse events.
The study will include 20 HIV-1-infected subjects, meeting all inclusion criteria and not meeting any exclusion criteria for this study.
- Conditions
- HIV-1 Infection
- Being tested
- Dolutegravir plus lamivudine
- Keywords
- HIV-1 naive infected patients, dual therapy, M184V mutation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dolutegravir plus lamivudineDrug
Also called dual therapy
Dolutegravir 50 mg QD plus lamivudine 300 mg QD
| Study group | Role | What they receive |
|---|---|---|
| single arm | Experimental | dolutegravir 50 mg QD plus lamivudine 300 mg QD Receives: Drug: Dolutegravir plus lamivudine |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV viral load efficacy at week 48
the proportion of patients with pVL < 50 copies/mL at week 48 using the ITT-exposed analysis (FDA snaphot).
Measured: 48 weeks
Secondary outcomes (5)
HIV viral resistance mutations
the number and the type of HIV resistance mutations among patients that meet the definition of virologic failure .
Measured: At week 48
HIV viral load efficacy at week 24
proportion of patients with <400 copies/mL and <50 copies/mL at weeks 24 and 36.
Measured: week 24 and week 36
immunological response in CD4 cell count
to measure and compare the absolute values of cd4 cells count in two points, at baseline visit and week 48, in this way we will evaluate the gain or increase of CD4 count cells during the study.
Measured: baseline and week 48
adverse events
To describe frequency, type and severity of clinical and laboratory adverse events based on DAIDS Adverse event grading table , version 2.1
Measured: baseline to 48 weeks
lipid profile change
to measure the change in cholesterol and triglyceride values. we are going to compare the value at the baseline visit and at week 48 for both deteminations, in this way we will evaluate the response or change on the lipid profile.
Measured: baseline and week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2022
- Study start22 May 2019
- Primary completionAug 2022 (estimated)
- Study completion30 Aug 2022 (estimated)
Why it stopped: Low recruitment, We did not find participants with the M184V mutation , inclusion criteria , throughout 230 resistance tests carried out
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-1 InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pedro Cahn
- Sponsor type
- University, hospital or other
- Collaborators
- ViiV Healthcare
- Responsible party
- Sponsor-investigator, Pedro Cahn, Fundación Huésped
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05295394
- Sponsor's protocol ID
- FH-42
- Acronym
- PADDLE184V
- Status last verified
- Apr 2022
- First submitted
- 25 Oct 2019
- Last updated
- 12 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: to publish week 48 study results
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dolutegravir-Lamivudine as Dual Therapy in naïve HIV-Infected Patients With Documented M184V Mutation:A Pilot Study
- ClinicalTrials.gov ID
- NCT05295394
- Acronym / sponsor ID
- PADDLE184V / FH-42
- Conditions
- HIV-1 Infection
- Keywords
- HIV-1 naive infected patients, dual therapy, M184V mutation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Low recruitment, We did not find participants with the M184V mutation , inclusion criteria , throughout 230 resistance tests carried out
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Pedro CahnUniversity, hospital or other
- Collaborators
- ViiV Healthcare
- Study start
- 22 May 2019 (actual)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- 30 Aug 2022 (estimated)
- First posted
- 25 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the antiviral efficacy, safety and tolerability of dual therapy with 3TC and DTG as initial therapy among naïve HIV patients with a documented M184V mutation.
Detailed description
This is a pilot study designed to evaluate the antiviral efficacy, safety and tolerability of dual therapy with 3TC and DTG as initial therapy among naïve HIV-1 subjects ≥ 18 years old carrying the M184V mutation
This will be evaluated as the proportion of patients with pVL < 50 copies/mL at week 48 using the ITT-exposed analysis (FDA snaphot).
This study will consist of a screening period of up to 42 days, a 48-week treatment period, followed by a 4-week post-treatment follow-up (FU) period to document late adverse events.
The study will include 20 HIV-1-infected subjects, meeting all inclusion criteria and not meeting any exclusion criteria for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single arm | Experimental | Drug: Dolutegravir plus lamivudinedolutegravir 50 mg QD plus lamivudine 300 mg QD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- ≥18 years of age.
- Documented HIV-1 infection defined as a positive rapid test or ELISA plus a plasma HIV-1 RNA ≥5,000 copies/mL or a reactive western blot.
- 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 (see Appendix 4).
- Naïve to ARV therapies (previous exposure to ARV drugs < 10 days).
- Documented M184V mutation associated with resistance to lamivudine in a previous genotypic test (last 3 months), or at screening.
Key exclusion criteria (15 listed)
- Patients will NOT be selected to be part of this study if they meet ANY of the following criteria:
- Alcohol or drug use that might impact on adherence
- Subjects positive for Hepatitis B at screening (+HBsAg), or anticipated need for Hepatitis C virus (HCV) therapy during the study
- Women who are pregnant or breastfeeding, or women who plan to become pregnant in the next 2 years
- interferon, interleukin-2, cytotoxic chemotherapy, Dofetilide (or pilsicainide) or immunosuppressors, antacid drugs containing Ca++ and or Mg++ at study entry
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dolutegravir plus lamivudineAlso: dual therapyDolutegravir 50 mg QD plus lamivudine 300 mg QD | Drug | single arm |
Primary outcome
HIV viral load efficacy at week 48
Time frame: 48 weeks
the proportion of patients with pVL < 50 copies/mL at week 48 using the ITT-exposed analysis (FDA snaphot).
5 secondary outcomes
HIV viral resistance mutations
Time frame: At week 48
HIV viral load efficacy at week 24
Time frame: week 24 and week 36
immunological response in CD4 cell count
Time frame: baseline and week 48
adverse events
Time frame: baseline to 48 weeks
lipid profile change
Time frame: baseline and week 48
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2022.
- Individual participant dataSharing planned: Yes. to publish week 48 study results
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dolutegravir plus lamivudine in people with HIV-1 Infection, 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 14 inclusion and 15 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: withdrawn, as of the sponsor's last update on 12 Apr 2022. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
HIV viral load efficacy 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?
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 12 Apr 2022.