A study to assess the efficacy and safety of the withdrawal of nucleos/tide analogues with resistance in multitreated HIV-1-infected subjects with virological suppressio
- Conditions
- Infection with human immunodeficiency virus (HIV).MedDRA version: 14.1Level: LLTClassification code 10008919Term: Chronic HIV infectionSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2012-000198-21-ES
- Lead Sponsor
- Fundació Lluita contra la SIDA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 90
1. HIV-1-infected subjects with age ?18 years old.
2. Receiving an antiretroviral therapy including NRTIs
3. Have a genotype before the start of the current antiretroviral regimen (if there is more than one genotupes availables, they will be added) documenting the existence of intermediate or complete resistance to one or more NRTIs, according to the criteria of the Spanish Network AIDS Research (ISR), this is? 3 score points. The presence of M184I/V indicates complete resistance to lamivudine or emtricitabine. In case of demonstrating complete resistance torwo NRTIs both drugs will be withdrawn simultaneously.
4. Receive at least two active drugs (sensitive) by the same algorithm, being one of them a boosted protease inhibitor. Is also considered as one active drug any NRTI that therefore can not be removed and will be maintained in the regime (eg, tenofovir). Raltegravir and enfuvirtide will be considered active if they are first used in the current regime. Maraviroc is considered active if it is documented R5 tropism before the start of the current regime and previously never failed to treatment with CCR5 antagonists.
5. The antiretroviral regimen must have been unchanged during the previous 6 moths.
6. Having a plasma HIV-1 RNA < 50 copies/mL during at least the previous 6 months, including at least two determinations, as well as in the inclusion moment.
7. Fertile women must use a barrier contraceptive method during the whole study.
8. Signature of informed 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 292
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1. Chronic hepatitis B infection (defined as HBsAg positive), even with normal AST/ALT values.
2. Any active neoplasia or AIDS-defining event.
3. Pregnant or breastfeeding.
4. Patients with a history of poor adherence or poor adherence anticipated by discretion of the investigator.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method