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
- Conditions
- Human Immunodeficiency Virus (HIV-1) infectionMedDRA version: 8.1Level: PTClassification code 10020161
- Registration Number
- EUCTR2005-005786-11-ES
- Lead Sponsor
- Gilead Sciences S.L.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 80
• 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method