Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02337322
Other study ID # Advanz-4
Secondary ID
Status Active, not recruiting
Phase Phase 4
First received
Last updated
Start date March 31, 2015
Est. completion date December 2019

Study information

Verified date August 2018
Source Hospital Clinic of Barcelona
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Dolutegravir

Darunavir/r


Locations

Country Name City State
Spain Hospital Clinic of Barcelona Barcelona BCN

Sponsors (1)

Lead Sponsor Collaborator
Juan A. Arnaiz

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Median CD4 T cell count increase 48 weeks
See also
  Status Clinical Trial Phase
Recruiting NCT02266992 - Exploring Novel Mechanisms of Vaccine Failure LAIV Pilot Study Phase 2
Recruiting NCT00974454 - Research on Effect of Traditional Chinese Medicine (TCM) on Immune Reconstitution of HIV/AIDS Patients After Highly Active Antiretroviral Therapy (HAART) N/A
Recruiting NCT00974519 - The Effect of Combination of Traditional Chinese Medicine (TCM) and Highly Active Antiretroviral Therapy (HAART) on Immune Reconstitution of HIV/AIDS Patients N/A
Recruiting NCT00974285 - Clinical Trials on the Effect of Immunity 1 (Fuzheng 1) on Immune Reconstitution of HIV Patients N/A
Recruiting NCT02542020 - Prospective Evaluation of HIV Patients Using Non-invasive Methods for Estimation of Liver Fibrosis and Steatosis
Completed NCT01766076 - Atorvastatin for HAART Suboptimal Responders Phase 3
Completed NCT01976715 - Study of People With HIV Infection Who Have High Viral Loads Despite Combination Antiretroviral Therapy
Completed NCT01840722 - Brief Intervention for Rural Women at High Risk for HIV/HCV N/A