Evaluation of Raltegravir Plus Maraviroc Therapy in Controlled HIV Patients Presenting With Lipohypertrophy

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2013-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Evaluation of antiretroviral therapy combining Raltegravir and Maraviroc in patients with virological success, presenting with clinical lipohypertrophy.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

R5 Integrase Study in HIV-1 Naive Patients

NCT01204905

HIV Infections

COMPLETED NA

Pilot Study of Maraviroc/Raltegravir for Naive HIV-1 Patients

NCT01291459

HIV

UNKNOWN PHASE2

Therapeutic Intensification Plus Immunomodulation to Decrease the HIV-1 Viral Reservoir

NCT00976404

HIV Infection

COMPLETED PHASE2

Impact of Maraviroc on the Immune Function in HIV-1 Infected Subjects Receiving Immunisation With Novel Antigens

NCT01049204

HIV Infections

TERMINATED PHASE4

Adding Maraviroc to the HAART Regimen of Well Controlled HIV-infected Patients

NCT02934022

HIV Infection

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Assess the ability to maintain the plasma HIV viral load below the threshold needed for detection (\< 50 copies/mL) at 24 weeks of raltegravir/maraviroc therapy without NRTIs and PIs, in patients with virological success and presenting with clinical lipohypertrophy.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Human Immunodeficiency Virus Lipohypertrophy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Raltegravir-Maraviroc

Raltegravir 400 mg twice a day + Maraviroc 300 mg twice a day

Group Type EXPERIMENTAL

Raltegravir-Maraviroc

Intervention Type DRUG

Raltegravir 400 mg twice a day + Maraviroc 300 mg twice a day

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Raltegravir-Maraviroc

Raltegravir 400 mg twice a day + Maraviroc 300 mg twice a day

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Isentress and Celsentri

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients infected with HIV-1 type B or CRF02.
* ≥ 18 years old
* Patients who have been receiving antiretroviral therapy for at least 5 years, and whose treatment has been stable for at least 6 months.
* Patients whose plasma viral load has been undetectable (below 200 copies/mL) over the last 24 months, and \< 50 copies/mL for at least 12 months.
* Patients with an R5\* tropic virus, as determined through DNA and with CD4 nadir ≥ 100/mm3
* Patients presenting with clinical lipohypertrophy recognized by themselves and by their doctors, and defined by increased volume of the abdominal and/or thoracic and/or cervical area (buffalo hump).
* Patients who have never been treated with raltegravir.
* Patients who have never been treated with maraviroc.
* Efficient contraception for women
* Free and informed written consent, signed by the patient and the investigator.
* Patients with health insurance. \* To increase the certainty of selecting patients with an R5 virus, the HIV-1 tropism will be determined by the genotype method and interpreted with the Geno2pheno\[coreceptor\] algorithm and a false positive rate threshold for X4 virus at 20%, rather than the usual 10%.

Exclusion Criteria

* X4, X4/5 or undetermined tropism of the HIV virus.
* HIV-2 or coinfection HIV-1/HIV-2.
* Chronic viral hepatitis B.
* Chronic viral hepatitis C requiring specific treatment over the first 24 weeks.
* Treatment with growth hormones.
* Hypolipemic or diabetes treatment, begun within the last 3 months.
* Pregnant or breastfeeding women.
* Haemoglobin \< 7g/dl, neutrophils \< 500/mm3, platelets \< 50 000/mm3, creatinine clearance \< 50 mL/min, alkaline phosphatases, ASAT, ALAT or bilirubin ≥ 3 times the upper limit of the normal range (N).
* Antiretroviral treatment associated to enzymatic inducer.
* Chronic alcohol consumption.
* Subjects under "sauvegarde de justice" (judicial protection due to temporarily and slightly diminished mental or physical faculties), or under legal guardianship.
* Subjects participating in another clinical trial evaluating different therapies and including an exclusion period that is still in force during the screening phase.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No