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

Phase 4

Completed

• Conditions: Human immunodeficiency virus (HIV); Infections and Infestations; Human immunodeficiency virus

• Registration Number: ISRCTN81993634
• Lead Sponsor: Gilead Sciences, SL (Spain)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04-11
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 80

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified