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Status unknownNCT02337322Updated Aug 3, 2018

Immune Recovery in Advanced , ARV-naïve, HIV-1-infected Individuals Taking Dolutegravir or Ritonavir-boosted Darunavir

A Phase 4 interventional study of Dolutegravir and Darunavir/r in Acquired Immune Deficiency Syndrome Virus, sponsored by Juan A. Arnaiz. Status unknown at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-08-03.

Sponsored by Juan A. Arnaiz · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2018), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
104
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

There are few randomized clinical trials in advanced HIV patients. This is a multicenter, randomized, open clinical trial, comparing 2 parallel groups, to compare the immunological reconstitution and the virological efficacy and safety of 2 different combinations of antiretroviral therapy given once a day (QD): abacavir plus lamivudine plus either dolutegravir, or darunavir-ritonavir during 96 weeks in advanced antiretroviral naïve HIV-1 infected patients with less than 100 CD4+ T-cells/mm3. Primary endpoint is the median increase in CD4+ T-cell count at 48 weeks after starting HAART.

02

Conditions studied

  • Acquired Immune Deficiency Syndrome Virus

Keywords

  • Acquired Immune Deficiency Syndrome Virus
  • HIV
  • HIV-1
  • Antiretroviral treatment
  • HIV Advanced Disease
  • AIDS
  • Dolutegravir
  • Darunavir
03

In context

Acquired Immunodeficiency Syndrome

2,040 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 272 are open to participants now.

This study's enrollment of 104 is close to the median of 105 across 1,543 interventional studies indexed under Acquired Immunodeficiency Syndrome.

Browse Acquired Immunodeficiency Syndrome studies →

Lead sponsor

Juan A. Arnaiz is the lead sponsor of 18 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. HIV patients > 18 years old who provide signed and dated informed consent.
  2. Male and female.
  3. Chronic HIV infection.
  4. Antiretroviral naïve.
  5. Confirmed CD4+ T cell count below 100 cells/mm3
  6. HLA B5701 negative patients.

Exclusion criteria

Exclusion Criteria:

  1. Active opportunistic infections requiring parenteral treatment
  2. Patients with cryptococcal meningitis treated with voriconazole
  3. AIDS-defining cancers needing chemotherapy.
  4. Female patients pregnant or breastfeeding.
  5. Patients with documented history of allergy to sulfonamides.
  6. Any contraindications to study drugs.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
104 participants (actual)

Study arms

  • Active comparator
    ABC+3TC+DTG

    Abacavir+lamivudine+Dolutegravir, QD, Single tablet Regimen

    Drug: Dolutegravir

  • Active comparator
    ABC+3TC+DRV/r

    Abacavir+lamivudine+ritonavir-boosted darunavir, QD

    Drug: Darunavir/r

Interventions

  • DrugDolutegravir
  • DrugDarunavir/r

    Also known as: Ritonavir-boosted Darunavir

06

What researchers measure

Primary outcomes

  1. Median CD4 T cell count increase

    Time frame: 48 weeks

07

Study locations

1 site
  • Hospital Clinic of Barcelona
    Barcelona, BCN 08013, Spain
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 3, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02337322
Lead sponsor
Juan A. Arnaiz
Responsible party
Juan A. Arnaiz (MD, PhD, Hospital Clinic of Barcelona) — Sponsor-investigator
First posted
Jan 13, 2015
Start date
Mar 31, 2015
Primary completion
Dec 2019 (estimated)
Completion
Dec 2019 (estimated)
Last update
Aug 3, 2018

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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