---
title: "Antiretroviral Treatment Guided by Proviral Genotype: Pilot Trial of Proof of Concept."
nct_id: NCT03539224
overall_status: UNKNOWN
phase: PHASE2
sponsor: Instituto de Investigación Hospital Universitario La Paz
study_type: INTERVENTIONAL
primary_condition: HIV-1-infection
countries: Spain
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03539224.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03539224"
ct_last_update_post_date: 2020-07-07
last_seen_at: "2026-05-12T06:11:45.115Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Antiretroviral Treatment Guided by Proviral Genotype: Pilot Trial of Proof of Concept.

**NCT ID:** [NCT03539224](https://clinicaltrials.gov/study/NCT03539224)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 41
- **Lead Sponsor:** Instituto de Investigación Hospital Universitario La Paz
- **Conditions:** HIV-1-infection
- **Start Date:** 2017-11-02
- **Completion Date:** 2021-07-31
- **CT.gov Last Update:** 2020-07-07

## Brief Summary

Phase IIa, open clinical trial, pilot, single arm and proof of concept.

## Detailed Description

Proof of concept trial evaluating safety and efficacy of treatment with Dolutegravir (DTG) + lamivudine (3TC) once daily in suppressed participants with history of previous treatment with 3TC or emtricitabine (FTC). Half of the participants will have history of failure with 3TC or FTC and M184V/I or K65R/E/N mutations in previous plasma genotypes, although to be eligible these mutations cannot be detectable at study entry in proviral DNA.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

1. HIV-1 infected patients.
2. Age\> 18 years.
3. Receiving stable antiretroviral treatment for at least 3 months.
4. Current or historical treatment with 3TC or FTC.
5. Willing to change antiretroviral treatment due to intolerance or interest in simplification.
6. Undetectable viral load (\<50 cop/mL) for at least 1 year prior to the inclusion. A single viral load \>50cop/ml (≤500 copies/ml) is allowed before the three months prior to inclusion in the study, preceded and followed by an undetectable determination.
7. Current level of CD4\> 350 cells/μL.
8. Naïve to integrase inhibitors.
9. Patient able to understand and give written informed consent.
10. For those included in group 1 (20 patients): No previous history of virological failure with ART regimen that included 3TC or FTC or previous virological failure had a population genotype without M184V/I or K65R/E/N mutations.
11. For those included in group 2 (20 patients): previous history of virological failure with ART regimen that included 3TC or FTC and historical genotype with M184V/I or K65R/E/N mutations.

Exclusion Criteria:

1. Detection of any of the following mutations in proviral DNA in peripheral blood by conventional sequencing: M184V/I or K65R/E/N.
2. Pregnant, lactating or child-bearing women who do not commit to using an adequate contraceptive method.
```

## Arms

- **Dolutegravir (DTG) + Lamivudine (3TC)** (EXPERIMENTAL) — Eligible subjects will receive one 50 mg tablet of DTG plus 300 mg 3TC tablet orally once daily upto 48 weeks

## Interventions

- **Dolutegravir (DTG)** (DRUG) — DTG 50 mg tablet will be orally administered once daily with or without food upto 48 weeks
- **Lamivudine (3TC)** (DRUG) — Lamivudine will be dispensed as 300 mg white, diamond shaped, scored, film coated tablets. It will be orally administered once daily with or without food upto 48 weeks.

## Primary Outcomes

- **Proportion of patients with undetectable viral load (<50 copies / mL) at 48 weeks** _(time frame: Week 48)_ — \- Efficacy: Proportion of patients with undetectable viral load (\<50 copies / mL) at 48 weeks of follow-up, according to the FDA snapshot algorithm in the population "by intention to treat-exposed". The intention-to-treat population includes all patients who have received at least one dose of DTG and 3TC.

## Secondary Outcomes

- **Proportion of patients with virological failure at 24 weeks** _(time frame: Week 24)_
- **Proportion of patients with virological failure at 48 weeks** _(time frame: Week 48)_
- **Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]** _(time frame: Since baseline visits to week 48)_
- **Evaluation of the appearance of genotypic resistance mutations (1)** _(time frame: Week 48)_

## Locations (2)

- Hospital 12 de Octubre, Madrid, Spain
- Hospital Universitario La Paz, Madrid, Spain

## Recent Field Changes (last 30 days)

- `outcomes.secondary` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.hospital 12 de octubre|madrid||spain` — added _(2026-05-12)_
- `locations.hospital universitario la paz|madrid||spain` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT03539224*  
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