Pilot phase IV, multicenter, randomized, open-label and controlled study to assess the evolution of peripheral body fat distribution after switching from AZT containing backbone to Truvada in HIV-1-infected patients on HAART (RECOMB Study) - RECOMB

Gilead Sciences S.L.0 个研究点目标入组 80 人开始时间: 2006年2月2日最近更新: 2022年4月19日

适应症

试验速览

暂无简介。

•HIV-1 infection documented by confirmed positive HIV-1 antibody test and/or positive PCR for HIV-1 RNA.
•Adult patients (over 18 years of age).
•Current HAART regimen containing AZT + 3TC at usual doses for at least during the previous 6 months.
•Viral load < 50 copies/mL on the last two consecutive determinations, under AZT containing HAART regimen.
•For women of childbearing potential, negative urine pregnancy test at screening visit.
•Agreement to take part in the study and sign the informed consent.
•Patients on lipid lowering treatment will be allowed to participate in the study only if the lipid-lowering treatment (either statins or fibrates) is stable for at least 8 weeks prior to screening and it is not expected to change this treatment during the first 3 months of the trial.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Patients on current TDF or FTC therapy.
•Patients with previous history of virological failure on FTC or TDF containing regimen.
•Patients receiving a non-registered antiretroviral (ARV) drug.
•Patients receiving a triple nucleoside-ARV combination.
•Hypersensitivity to one of the components of the dosage forms of TDF or FTC, or previous history of intolerance to one of these drugs.
•Known history of drug abuse or chronic alcohol consumption
•Women who are pregnant of breast feeding or female of childbearing potential who do not use an adequate method of contraception according to the investigator’s judgment.
•Current active opportunistic infection or documented infection within the previous 4 weeks.
•Documented active malignant disease (excluding Kaposi sarcoma limited to the skin).
•Renal disease with creatinine clearance < 50 mL/min.
•Concomitant use of nephrotoxic or immuno-suppressive drugs which could not be stopped without affecting the safety of the patient.
•Receiving on-going therapy with systemic corticosteroids, Interleukin-2 (IL-2) or chemotherapy.
•Patients who are not to be included in the study according to the investigator’s criterion.

发起方

Gilead Sciences S.L.