EUCTR2016-005226-11-ES
Active, not recruiting
Phase 1
Phase 4 clinical trial, randomized to evaluate the effect on immune recovery of triple antiretroviral maintenance therapy (elvitegravir / cobicistat 150/150 mg + tenofovir + emtricitabine alapenamide 10 mg 200 mg) versus simplification of combination therapy (dolutegravir + lamivudine or darunavir / Cobicistat + lamivudine) in HIV-infected patients with sustained undetectable viremia.
Fundación Pública Andaluza para la Gestión en Salud de Sevilla (FISEVI)0 sites180 target enrollmentJanuary 25, 2017
ConditionsAdult patients with HIV infection on stable therapy (= 6 months) with triple therapy and undetectable viremia for = 1 year.MedDRA version: 19.1Level: LLTClassification code 10049838Term: HIV viral load undetectableSystem Organ Class: 100000004848MedDRA version: 19.1Level: PTClassification code 10077716Term: HIV viraemiaSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Not possible to specify
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Adult patients with HIV infection on stable therapy (= 6 months) with triple therapy and undetectable viremia for = 1 year.
- Sponsor
- Fundación Pública Andaluza para la Gestión en Salud de Sevilla (FISEVI)
- Enrollment
- 180
- Status
- Active, not recruiting
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Patients with HIV infection and age \= 18 years.
- •\- Initiation of antiretroviral treatment after 01/01/2013
- •\- Undetectable viremia (\<20 copies / ml for at least one year) with triple therapy.
- •\- Nadir and CD4 \+ T lymphocyte count \=200 / µl at the time of inclusion.
- •Informed written consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 160
- •F.1\.3 Elderly (\>\=65 years) yes
Exclusion Criteria
- •\- Presence of major resistance mutations to any of the study drugs.
- •\- Opportunistic infections active at the time of inclusion.
- •\- Pregnancy at the time of inclusion or during the follow\-up period.
- •\- Active co\-infection with B or C virus of hepatitis.
- •\- Cirrhosis, portal hypertension and / or hypersplenism of any etiology.
- •\- Past or current neoplasms of steroid treatment, immunomodulators, or chemotherapy
- •\- Laboratory abnormalities grade 3 or 4\.
- •\- Concomitant use of drugs with higher drug interactions with study drugs, according to respective product data sheets.
- •\- Estimated creatinine clearance \<50ml / min.
- •\- Withdrawal of informed consent.
Outcomes
Primary Outcomes
Not specified
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