MedTrace Logo

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

NCT04880395 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 265

Last updated 2025-07-30

Study results available
· View outcomes & findings →

Summary

Protocol Title: DOLCE: Dolutegravir-Lamivudine for naïve HIV-Infected Patients with ≤200 CD4/mm3

Protocol Number: FH-57

Study Objectives: To assess the antiviral activity at week 48 of DTG+3TC among naïve HIV patients with a CD4 count ≤200 cells /mm3.

Conditions

Interventions

DRUG

Intervention Arm: dolutegravir/lamivudine

1 pill QD

DRUG

Comparator ARM: TDF/XTC plus Dolutegravir (XTC stand for lamivudine OR emtricitabine)

1 pill of each QD

Sponsors & Collaborators

  • ViiV Healthcare

    collaborator INDUSTRY

  • Federal University of Bahia

    collaborator OTHER

  • Fundación Huésped

    lead OTHER

Principal Investigators

  • Maria Ines Figueroa, PI · Fundación Huésped

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-17
Primary Completion
2024-05-07
Completion
2024-05-07

Countries

  • Argentina
  • Brazil

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04880395 on ClinicalTrials.gov