Evaluation of Raltegravir Plus Maraviroc Therapy in Controlled HIV Patients Presenting With Lipoh… (NCT01420523) | Clinical Trial Compass
TerminatedPhase 2
Evaluation of Raltegravir Plus Maraviroc Therapy in Controlled HIV Patients Presenting With Lipohypertrophy
France48 participantsStarted 2011-12
Plain-language summary
Evaluation of antiretroviral therapy combining Raltegravir and Maraviroc in patients with virological success, presenting with clinical lipohypertrophy.
Who can participate
Age range18 Years
SexALL
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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, begu…