Immune Recovery in Advanced , ARV-naïve, HIV-1-infected Individuals Taking Dolutegravir or Ritonavir-boosted Darunavir

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2019-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Acquired Immune Deficiency Syndrome Virus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ABC+3TC+DTG

Abacavir+lamivudine+Dolutegravir, QD, Single tablet Regimen

Group Type ACTIVE_COMPARATOR

Dolutegravir

Intervention Type DRUG

ABC+3TC+DRV/r

Abacavir+lamivudine+ritonavir-boosted darunavir, QD

Group Type ACTIVE_COMPARATOR

Darunavir/r

Intervention Type DRUG

Interventions

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Dolutegravir

Intervention Type DRUG

Darunavir/r

Intervention Type DRUG

Other Intervention Names

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Ritonavir-boosted Darunavir

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No