deltatrials
Completed PHASE4 INTERVENTIONAL 2-arm NCT04880395

Dolutegravir-Lamivudine for naïve HIV-Infected Patients With ≤200 CD4/mm3 (DOLCE)

Sponsor: Federal University of Bahia

Conditions HIV-1-infection
Interventions Comparator ARM: TDF/XTC plus Dolutegravir (XTC stand for lamivudine OR emtricitabine) Intervention Arm: dolutegravir/lamivudine
Updated 7 times since 2021 Last updated: Jul 29, 2025 Started: May 17, 2021 Primary completion: May 7, 2024 Completion: May 7, 2024
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE4 clinical study on HIV-1-infection, this trial is completed. The trial is conducted by Federal University of Bahia and has accumulated 7 data snapshots since 2021. Infectious disease trials contribute critical data for public health response and treatment development.

Status Flow

~Jun 2021 – ~Oct 2021 · 4 months · monthly snapshotNot Yet Recruiting~Oct 2021 – ~Sep 2022 · 11 months · monthly snapshotRecruiting~Sep 2022 – ~Apr 2023 · 7 months · monthly snapshotRecruiting~Apr 2023 – ~Jul 2024 · 15 months · monthly snapshotRecruiting~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotRecruiting~Sep 2024 – ~Aug 2025 · 11 months · monthly snapshotCompleted~Aug 2025 – present · 13 months · monthly snapshotCompleted

Change History

7 versions recorded

  1. Aug 2025 — Present [monthly]

    Completed PHASE4

  2. Sep 2024 — Aug 2025 [monthly]

    Completed PHASE4

    Status: Recruiting → Completed

  3. Jul 2024 — Sep 2024 [monthly]

    Recruiting PHASE4

  4. Apr 2023 — Jul 2024 [monthly]

    Recruiting PHASE4

  5. Sep 2022 — Apr 2023 [monthly]

    Recruiting PHASE4

▶ Show 2 earlier versions

  1. Oct 2021 — Sep 2022 [monthly]

    Recruiting PHASE4

    Status: Not Yet Recruiting → Recruiting

  2. Jun 2021 — Oct 2021 [monthly]

    Not Yet Recruiting PHASE4

    First recorded

May 2021

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Federal University of Bahia
  • Fundación Huésped
  • ViiV Healthcare
Data source: Fundación Huésped

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations