Pilot Opened Trial in HIV-infected Patients Including an Investigational Marketed Product

NCT00773708 | Completed Phase 4

• 1 other identifier: DISCOR-RAL
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to provide new knowledge about the pathogenesis of HIV infection, specifically, the role that immune activation and apoptotic activity play in immune recovery, and in particular, in the paradoxical immunologic response of some patients on antiretroviral therapy despite achievement of sustained and complete viral suppression. In this regard, the investigators will prospectively evaluate the impact of intensification with Raltegravir in those "discordants" patients with high index of immune activation, measured as the percentage of CD8+HLADR+CD38+ cells. This will provide relevant information on the effectiveness of this drug in guided intensification regimens.

Conditions

HIV Infections

Keywords

HIV infection; Discordant patient; CD4 recovery; intensification antiretroviral therapy; raltegravir; HIV-1 infected patient classified as "discordant" who showed high level of CD8+HLADR+CD38+ and cell death values at the screening

Outcome Measures

Primary Outcomes (1)

• CD4 cell count

  From Basal to 48 week (last visit) every 3 months

Secondary Outcomes (5)

• Epidemiologic variables: Age, sex, time of HIV diagnosis/duration of HIV infection, duration of antiretroviral treatment with HAART, duration of treatment with a PI, HIV infection status/CDC disease stage. Epidemiologic, virologic, and immunologic data

  Baseline

• Virologic and immunologic variables: Time/duration of viral suppression, nadir CD4+ count, change in CD4+ count (absolute and percentage) since initiation of antiretroviral therapy, since initiation of HAART, and since achieving and undetectable viral

  From Basal to 48 week (last visit) every 3 months

• Apoptotic variables: Cell death in CD4 and CD8 cells, defined as the percentage of cells which present a weak DIOC measurement (DIOC low) after 1 or 4 days of culture.

  From Basal to 48 week (last visit) every 3 months

• The toxicity parameters will be evaluated: Hematology: Hematocrit, red blood cell count, hemoglobin, MCV, lymphocyte, platelet count, quick Index. • Biochemistry: glucose, total cholesterol, HDL and LDL cholesterol, triglycerides, urea, creatinine, A

  From Basal to 48 week (last visit) every 3 months

• Clinical adverse effects and clinical events

  From Basal to 48 week (last visit) every 3 months

Study Arms (2)

1

EXPERIMENTAL

intensify their triple-drug therapy with Raltegravir (RAL)

Drug: raltegravir

2

NO INTERVENTION

Continue with the same antiretroviral therapy

Interventions

raltegravir DRUG

intensify their therapy with Raltegravir(RAL):1 Protease inhibitor plus 2 nucleoside reverse transcriptase inhibitor plus RAL or 1 non-nucleoside reverse transcriptase inhibitor plus 2 nucleoside reverse transcriptase inhibitor plus RAL

Also known as: N/P.

1

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patient having a diagnosis of HIV infection, on continuously HAART for at least 2 years, including:
• NRTI/NtRTIs (except ddI+TDF), plus
• PI/ritonavir (lopinavir/ritonavir, atazanavir/ritonavir, fosamprenavir/ritonavir, tipranavir/ritonavir, darunavir/ritonavir) or 1 NNRTI (nevirapine or efavirenz)
• Undetectable plasma HIV-1 RNA (VL \< 50 copies/mL) during the last 2 years prior to screening (with at least 4 determinations of viral load during this time period).
• Good treatment adherence.
• No presence of other factors which could contribute to CD4+ declines, such as treatment with chemotherapy, treatment with interferon/ribavirin, a ddI+TDF-containing regimen, etc, at least 12 months prior to screening.
• Patient classified as "discordant" who showed high level of CD8+HLADR+CD38+ and cell death values at the screening (see reference values in the definition section in page 9: 4.2. AIMS).
• Voluntary written informed consent.

You may not qualify if:

• Pregnancy or fertile women willing to be pregnant.
• Hepatic toxicity (AST, ALT levels grade +/= 3).

Sponsors & Collaborators

• Germans Trias i Pujol Hospital: lead

Study Sites (1)

H.U. Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Raltegravir Potassium

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Eugenia Negredo

Study Record Dates

• First Submitted: October 14, 2008
• First Posted: October 16, 2008
• Study Start: March 1, 2009
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: March 11, 2015

Record last verified: 2011-09

Locations

ES (1)