Acquired Immune Deficiency Syndrome Virus Clinical Trial
Official title:
Immune Reconstitution in Severely Immunosuppressed Antiretroviral-naive HIV-1-Infected Patients (<100 CD4+ T Cells/μL) Taking Antiretroviral Regimens Based on Dolutegravir or Ritonavir-boosted Darunavir (the Advanz-4 Trial).
Verified date | August 2018 |
Source | Hospital Clinic of Barcelona |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 104 |
Est. completion date | December 2019 |
Est. primary completion date | December 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Clinic of Barcelona | Barcelona | BCN |
Lead Sponsor | Collaborator |
---|---|
Juan A. Arnaiz |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Median CD4 T cell count increase | 48 weeks |
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