Phase 4
N=230
Dolutegravir-Lamivudine for naïve HIV-Infected Patients With ≤200 CD4/mm3
HIV-1-infection
Bottom Line
View on ClinicalTrials.gov: NCT04880395 ↗Enrolled (actual)
230
Serious AEs
10.5%
Results posted
Jul 2025
Primary outcome: Primary: Antiviral Activity at Week 48 of DTG+3TC Among ART-naïve HIV Patients With a CD4 Count ≤200 Cells/mm3. — 125; 62 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Intervention Arm: dolutegravir/lamivudine (Drug); Comparator ARM: TDF/XTC plus Dolutegravir (XTC stand for lamivudine OR emtricitabine) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Fundación Huésped
- Primary completion
- May 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Antiviral Activity at Week 48 of DTG+3TC Among ART-naïve HIV Patients With a CD4 Count ≤200 Cells/mm3. |
125; 62 | — |
| SECONDARY Antiviral Activity of DTG+3TC and DTG+TDF/XTC (TDF/FTC or TDF/3TC) at Week 24 |
110; 58 | — |
| SECONDARY Safety and Tolerability of DTG+3TC and DTG+TDF/XTC Over Time |
7; 2 | — |
| SECONDARY Antiviral Activity of DTG+3TC and DTG+TDF/XTC at Week 48 in Patients With Baseline Viral Load >100,000 c/mL |
76; 36 | — |
| SECONDARY Changes in Lymphocytes Subsets Between Baseline and 48 Weeks |
200; 177 | — |
| SECONDARY Development of HIV-1 Resistance in Patients With Virologic Failure or Viral Rebound Whilst Being Treated With DTG+3TC or DTG+TDF/XTC |
0; 0 | — |
| SECONDARY Incidence of IRIS or Disease Progression (HIV Associated Conditions, AIDS and Death). |
9; 6 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
- Documented HIV-1 infection defined as a positive rapid test or ELISA plus a plasma HIV-1 RNA (>1,000 copies/mL) or a positive western blot. A previous result performed on the last 30 days can be used.
- ≥18 years of age
- Naïve to ARV therapies (defined as ≤ 10 days of prior therapy with any antiretroviral therapy following an HIV diagnosis). Previous use of PrEP or PEP is allowed if there is documented HIV seronegativity between the last prophylactic dose and the date of HIV diagnosis.
- HIV RNA at screening visit > or = 1,000 copies/mL. A previous result performed on the last 30 days can be used.
- CD4 at screening 15%. If the subject does not have a previous resistance test, samples will be taken at the screening visit and the subject can be randomized and start the study. while awaiting the results (see section 4.8).
- Any verified Grade 4 abnormality.
- 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.
Data sourced from ClinicalTrials.gov (NCT04880395). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.