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| Pilot phase IV, multicenter, randomized, open-label and controlled study to assess the evolution of peripheral body fat distribution after switching from zidovudine-containing backbone to truvada in HIV-1-infected patients on highly active antiretroviral therapy |
| ISRCTN | ISRCTN81993634 |
| ClinicalTrials.gov identifier | |
| Public title | Pilot phase IV, multicenter, randomized, open-label and controlled study to assess the evolution of peripheral body fat distribution after switching from zidovudine-containing backbone to truvada in HIV-1-infected patients on highly active antiretroviral therapy |
| Scientific title | |
| Acronym | RECOMB |
| Serial number at source | GS-ES-164-0154 |
| Study hypothesis | Eligible patients must have been on zidovudine (AZT) treatment for at least six months. The rational for this criterion is that it has been widely described that after this period of time, sub-clinical body fat changes can be developed, related to alterations in mitochondrial function and replication capacity of the subcutaneous adipose tissue. These changes could lead to an objective lipoatrophy (loss of 20% of peripheral fat) several months later. To assess the potential benefit of switching to truvada is the main objective for this study. Another objective of this study is to evaluate the changes in body fat distribution as measured by dual-energy x-ray absortiometry (DEXA) after switching from AZT-containing backbone to truvada |
| Lay summary | |
| Ethics approval | Approved by the Ethics Committee of the Hospital Vall d'Hebron, Barcelona, Spain on 10/03/2006 |
| Study design | Pilot, phase IV, multicenter, open-labelled, randomized controlled study |
| Countries of recruitment | Spain |
| Disease/condition/study domain |
Human immunodeficiency virus (HIV) |
| Participants - inclusion criteria |
1. Human immunodeficiency virus (HIV-1) infection as documented by positively confirmed HIV-1 antibody test and/or positive polymerase chain reaction (PCR) for HIV-1 ribonucleic acid (RNA) 2. Adult patients (over 18 years of age) 3. Currently on highly active antiretroviral therapy (HAART) regimen, containing zidovudine and lamivudine at usual doses for at least six months 4. Viral load <50 copies/ml on the last two consecutive determinations under zidovudine and lamivudine-containing HAART regimen 5. For women of childbearing potential, negative urine pregnancy test at screening visit 6. Agreement to take part in the study and signed informed consent form 7. 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 eight weeks prior to screening and is not expected to change this treatment during the first three months of the trial |
| Participants - exclusion criteria |
1. Patients on current transdermal fentanyl (TDF) or emtricitabine (FTC) therapy 2. Patients with a previous history of virological failure on FTC or TDF-containing regimen 3. Patients receiving a non-registered antiretroviral (ARV) drug 4. Patients receiving a triple nucleoside-ARV combination 5. Hypersensitivity to one of the components of the dosage forms of TDF or FTC, or previous history of intolerance to one of these drugs 6. Known history of drug abuse or chronic alcohol consumption 7. Women who are pregnant or breast-feeding or females of childbearing potential who do not use an adequate method of contraception according to the investigator’s judgment 8. Current active opportunistic infection or documented infection within the previous four weeks 9. Documented active malignant disease (excluding Kaposi’s sarcoma limited to the skin) 10. Renal disease with creatinine clearance <50 ml/min 11. Concomitant use of nephrotoxic or immuno-suppressive drugs, which cannot be stopped without affecting the safety of the patient 12. Receiving on-going therapy with systemic corticosteroids, interleukin-2 (IL-2) or chemotherapy 13. Patients not to be included in the study according to the investigator’s criterion |
| Anticipated start date | 05/04/2006 |
| Anticipated end date | 12/12/2007 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 80 |
| Interventions | Patients on current HAART regimen containing zidovudine and lamivudine at usual doses for at least six months, will be randomised to switch to truvada (fixed-dose combination of tenofovir and emtricitabine) or to continue with the same HAART regimen containing zidovudine and lamividine. The other drugs included in the original HAART regimen will not change. |
| Primary outcome measure(s) |
Objective assessment of change from baseline in limb fat at week 48 as measured by DEXA 1. Dual-energy x-ray absortiometry (DEXA) scans will be performed at baseline, week 24, week 48 and week 72 2. Study of mitochondrial toxicity at baseline, week 12, week 24, week 48 and week 72 |
| Secondary outcome measure(s) |
1. Change in the mitochondrial deoxyribonucleic acid (DNA) or nuclear DNA ratio in the different visits compared with baseline 2. Change in lactate concentration in the different visits compared with baseline 3. Proportion of patients who maintain confirmed HIV-1 RNA levels of <50 copies per ml 4. Proportion of patients with HIV-1 RNA levels between >50 and <400 copies per ml 5. Proportion of patients with virologic failure as confirmed by two consecutive HIV-1 RNA >400 copies/ml 6. Time to loss of virological response, defined as the time elapsed from the patient’s first dose of study drug to confirmed HIV-1 RNA levels of >50 and <400 copies/ml, death caused by the disease, medication discontinuation, or addition of a new antiretroviral medication 7. Time to definite virological failure, defined as the time elapsed from the patient’s first dose of study drug to confirmed HIV-1 RNA levels of >400 copies/ml 8. Change in CD4+ cell counts in the different study visits compared with baseline 9. Change in serum triglycerides, total cholesterol, low-density lipoprotein (LDL), and high-density lipoprotein (HDL) fractions in the different study visits compared with baseline 10. Change in hemoglobin and hematocrit concentrations in the different visits compared with baseline 11. Proportion of patients with different specific mutations after virological failure 12. Proportion of patients who show treatment adherence |
| Sources of funding | Gilead Sciences, SL |
| Trial website | |
| Publications | |
| Contact name | Prof Esteban Ribera Pascuet |
| Address |
Hospital Vall d'Hebrón Passeig de Vall D'Hebrón, 119-129 |
| City/town | Barcelona |
| Zip/Postcode | 08035 |
| Country | Spain |
| Sponsor | Gilead Sciences, SL (Spain) |
| Address |
C/Agustin de Foxá, 27 Piso 9 |
| City/town | Madrid |
| Zip/Postcode | 28036 |
| Country | Spain |
| Sponsor website: | http://www.gilead.com |
| Date applied | 23/01/2006 |
| Last edited | 18/04/2006 |
| Date ISRCTN assigned | 11/04/2006 |
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| © 2012 ISRCTN unless otherwise stated. | |
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