E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Human Immunodeficiency Virus (HIV-1) infection |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10020161 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To explore changes in limb fat assessed by DEXA measurements, after the substitution of the Zidovudine + Lamivudine NRTI-backbone by Truvada (TDF+FTC) versus maintaining the original Zidovudine-containing regimen without any change, through 48 wk. |
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E.2.2 | Secondary objectives of the trial |
• To explore changes in the mtDNA/nDNA ratio in PBMC in each study group.
• To assess the proportion of patients with HIV RNA < 400 and < 50 copies/mL during the follow-up weeks (weeks 12-72) in each group.
• To assess changes in CD4+ cell count in each group throughout the study.
• To monitor the safety profile of both treatment arms, recording all adverse events that may appear during the study.
• To define the resistance profile in case of virological failure.
• To assess the changes in hemoglobin and hematocrit levels in each group.
• To assess metabolic parameters in each group (total cholesterol, HDLc, LDLc, triglycerides, lactic acid).
• To assess patient adherence |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
• 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.
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E.4 | Principal exclusion criteria |
• 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. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Objective assessment: of change from baseline in limb fat at Week 48 as measured by DEXA. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Current regimen (dual nucleoside antiretroviral including zidovudine) |
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E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |