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Dolutegravir/Lamivudine Dual Therapy for ART-naïve People With HIV and TB Receiving Rifampin-based TB Treatment

ConditionsTuberculosisHIV
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age15-99
SponsorJohns Hopkins University

About this trial

This will be a Phase IIIb Clinical Trial, an international multicenter, randomized, three-arm, non-comparative trial of efficacy, safety, and tolerability of the dual therapy regimen dolutegravir plus lamivudine either twice daily or DTG/3TC ( Dovato) in the morning +dolutegravir (DTG) in the evening, versus standard of care (SOC) twice-daily dolutegravir plus 2 once-daily Nucleoside reverse-transcriptase inhibitors (NRTIs) tenofovir disoproxil fumarate /lamivudine (TDF/3TC), among antiretroviral therapy (ART)-nave individuals with HIV-1 receiving rifampin-based TB therapy

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Documentation of HIV-1 status: HIV-1 infection, documented by any licensed rapid HIV test or HIV-1 enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to entry and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen, or plasma HIV 1 RNA viral load. Two or more HIV-1 RNA viral loads of >1,000 copies/mL are also acceptable as documentation of HIV-1 infection.

CD4+ cell count ≥50 cells/mm3 obtained within 30 days prior to study entry

HIV-1 viral load ≥1000 copies/mL

ART-naïve.

Disqualifiers

Pregnant, or plans to become pregnant.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dolutegravir 50mg Tab

    Drug

    Participants will receive Dolutegravir 50mg

  • Dolutegravir/Lamivudine 50 MG-300mg Oral Tablet [DOVATO]

    Drug

    Participants will receive Dolutegravir/Lamivudine 50 MG-300 MG Oral Tablet \[DOVATO\]

  • Dolutegravir plus Tenofovir disoproxil fumarate (TDF)/ lamivudine (3TC)

    Drug

    Participants will receive Dolutegravir plus Tenofovir disoproxil fumarate (TDF)/ lamivudine (3TC)

Treatment groups

150 Participants
are divided into 3 treatment groups
Group A: Arm 1: DTG 50 mg/ 3TC 300mg (Dovato®) twice daily (BID)Experimental treatment 1 intervention
Group B: Arm 2: DTG 50 mg/ 3TC 300mg (Dovato®) once daily (QD) in the morning with DTG 50 mg in the eveningExperimental treatment 2 interventions
Group C: Arm 3: Standard of Care 3-drug ART (DTG+ TDF/3TC) plus DTG 50mg in the evening.Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Among treatment-naïve participants with HIV-1 who are taking rifampin-based regimens for TB, determine the proportion with HIV-1 virologic suppression (via FDA snapshot algorithm) at 28 weeks of HIV treatment, by arm

To Compare the proportion of participants with HIV-1 virologic suppression at 28 weeks of HIV treatment by arm.

Time frame
28 weeks

Secondary outcomes

1

1.3.1 Number of patients with HIV-1 virologic suppression (via FDA snapshot algorithm) at 48 weeks, in each arm

To compare the proportion in each arm above DTG protein adjusted 90% inhibitory concentration (IC90) (64 ng/mL) at each PK sampling.

Time frame
48 weeks
2

1.3.2 Number of patients with HIV-1 virologic suppression at 48 weeks, in the combined DTG/3TC arms (Arm 1 + Arm 2)

To compare the proportion of patients with HIV-1 virologic suppression at 48 weeks, in the combined DTG/3TC arms (Arm 1 + Arm 2)

Time frame
48 weeks
3

1.3.3 Change from baseline in CD4 over 28 weeks and 48 weeks of HIV treatment, by arm

To compare the changes from baseline over 28 weeks and 48 weeks of HIV treatment by the arm.

Time frame
28 weeks, 48 weeks
4

1.3.4 Proportion of participants with DTG Cmin above target DTG trough of 158 ng/mL

1-To estimate the pharmacokinetics (PK) of DTG when given twice daily as a 50 mg/ 300 mg DTG/3TC FDC with rifampicin (RIF)-containing TB treatment, X DTG 50 mg/ 3TC 300 mg FDC given once daily without RIF among the same participants after completing TB treatment.

Time frame
2years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Johns Hopkins University

Lead sponsor

ViiV Healthcare

Collaborator

Source ClinicalTrials.gov
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