NCT02588820

Brief Summary

Pilot study to evaluate the impact of extremely early ART in the dynamics of viral reservoir, immune activation and inflammation in patients with HIV-1 infection of less than 20 days (Fiebig stages I-II) compared to patients with infection of 20-100 days (Fiebig stages III-V), to induce HIV functional cure.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for phase_3 hiv-infections

Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 20, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 28, 2015

Completed
5 months until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

August 17, 2016

Status Verified

August 1, 2016

Enrollment Period

2.6 years

First QC Date

October 20, 2015

Last Update Submit

August 16, 2016

Conditions

HIV Infections

Keywords

HIV

Outcome Measures

Primary Outcomes (1)

  • Functional cure (Proportion of patients with undetectable viral reservoir)

    Proportion of patients in both groups with undetectable viral reservoir in peripheral and rectal tissue CD4+ T cells. A viral load will be performed at 1, 3 and 12 months after ART initiation and in rectal tissue at one year post-ART initiation.

    12 months of treatment

Secondary Outcomes (5)

  • Proportion of patients with undetectable plasmatic HIV viral load

    1, 3 and 12 months post-stop antiretroviral treatment will be evaluated.

  • Level of reduction of viral reservoir among patients treated in phase I-II Fiebig and patients treated in Fiebig stage III-V

    1, 3, 12 months will be measured in patients on antiretroviral treatment and at 1, 3, 12 months post-stop

  • Level of reduction of bacterial translocation among patients treated in phase I-II Fiebig and patients treated in Fiebig stage III-V

    1, 3, 12 months will be measured in patients on antiretroviral treatment and at 1, 3, 12 months post-stop

  • Level of reduction of immune activation among patients treated in phase I-II Fiebig and patients treated in Fiebig stage III-V

    1, 3, 12 months will be measured in patients on antiretroviral treatment and at 1, 3, 12 months post-stop

  • Level of reduction of inflammation among patients treated in phase I-II Fiebig and patients treated in Fiebig stage III-V

    1, 3, 12 months will be measured in patients on antiretroviral treatment and at 1, 3, 12 months post-stop

Study Arms (1)

Antiretroviral treatment

EXPERIMENTAL
Drug: Antiretroviral Therapy (Experimental)

Interventions

Antiretroviral Therapy (Experimental)DRUG

1. Initial ART until HLA-B5701 results became available (48 hours): 1. Tenofovir 245 mg once a day 2. Emtricitabine 200 mg once a day 3. Dolutegravir 50 mg once a day 4. Darunavir 800 mg once a day 5. Ritonavir 100 mg once a day 6. Maraviroc 150 mg twice a day 2. Three months continuation treatment (after HLA-B5701 confirmed as negative): 1. Dolutegravir 50 mg once a day. 2. Abacavir 600 mg once a day 3. Lamivudine 300 mg once a day 4. Darunavir 800 mg once a day 5. Ritonavir 100 mg once a day 6. Maraviroc 150 mg twice a day The whole treatment schedule comprises 7 pills per day (in a single dose), except for maraviroc, which will be given twice daily. 3. Nine months continuation treatment (till complete 12 months treatment): 1. Abacavir, 600mg once a day 2. Lamivudine, 300 mg once a day 3. Dolutegravir, 50 mg once a day

Antiretroviral treatment

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men who have sex with men
  • Male's between18 and 65 years old
  • Less than 100 days of infection
  • Patient stage Fiebig I to V
  • Negative or Incomplete western blot with negative p31 band

You may not qualify if:

  • P31 positive band in western blot
  • Active oncological disease
  • Active hepatitis C virus infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clínic i Provincial de Barcelona

Barcelona, Barcelona, 08036, Spain

RECRUITING

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Research Manager

Study Record Dates

First Submitted

October 20, 2015

First Posted

October 28, 2015

Study Start

April 1, 2016

Primary Completion

November 1, 2018

Study Completion

November 1, 2018

Last Updated

August 17, 2016

Record last verified: 2016-08

Locations

ES(1)