Impact of Extremely Early Antiretroviral Therapy to Reduce VIral REservoir and Induce Functional CURE of HIV-1 Infection

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2018-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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HIV Infections

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Antiretroviral treatment

Group Type EXPERIMENTAL

Antiretroviral Therapy (Experimental)

Intervention Type 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

Interventions

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Antiretroviral Therapy (Experimental)

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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