Acquired Immune Deficiency Syndrome Virus
Conditions
Keywords
Acquired Immune Deficiency Syndrome Virus, HIV, HIV-1, Antiretroviral treatment, HIV Advanced Disease, AIDS, Dolutegravir, Darunavir
Brief summary
There are few randomized clinical trials in advanced HIV patients. This is a multicenter, randomized, open clinical trial, comparing 2 parallel groups, to compare the immunological reconstitution and the virological efficacy and safety of 2 different combinations of antiretroviral therapy given once a day (QD): abacavir plus lamivudine plus either dolutegravir, or darunavir-ritonavir during 96 weeks in advanced antiretroviral naïve HIV-1 infected patients with less than 100 CD4+ T-cells/mm3. Primary endpoint is the median increase in CD4+ T-cell count at 48 weeks after starting HAART.
Interventions
DRUGDolutegravir
DRUGDarunavir/r
Sponsors
Juan A. Arnaiz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. HIV patients \> 18 years old who provide signed and dated informed consent. 2. Male and female. 3. Chronic HIV infection. 4. Antiretroviral naïve. 5. Confirmed CD4+ T cell count below 100 cells/mm3 6. HLA B5701 negative patients.
Exclusion criteria
1. Active opportunistic infections requiring parenteral treatment 2. Patients with cryptococcal meningitis treated with voriconazole 3. AIDS-defining cancers needing chemotherapy. 4. Female patients pregnant or breastfeeding. 5. Patients with documented history of allergy to sulfonamides. 6. Any contraindications to study drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Median CD4 T cell count increase | 48 weeks |
Countries
Spain
Outcome results
None listed