NCT02588820

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

Impact of Extremely Early Antiretroviral Therapy to Reduce VIral REservoir and Induce Functional CURE of HIV-1 Infection: A Pilot Comparative Study

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: David Garcia Cinca · Academic / Other
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	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

Timeline

• Start date: 2016-04-01
• Primary completion: 2018-11-01
• Completion: 2018-11-01
• First posted: 2015-10-28
• Last updated: 2016-08-17

Locations

1 site across 1 country: Spain