Peripheral Body Fat Distribution After Switching Zidovudine and Lamivudine to Truvada

NCT00324649 | Completed Phase 4 Results DMC

• 1 other identifier: GS-ES-164-0154
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluated changes in body fat distribution in human immunodeficiency virus type 1 (HIV-1) infected participants who either switched from a zidovudine- plus lamivudine- containing highly active antiretroviral therapy (HAART) regimen to a regimen containing Truvada® (a fixed-dose combination tablet of emtricitabine \[FTC, 200 mg\] and tenofovir disoproxil fumarate \[TDF, 300 mg\]) or who remained on a zidovudine- plus lamivudine-containing regimen. Subjects continued their protease inhibitor (PI) or nonnucleoside reverse transcriptase inhibitor (NNRTI).

Conditions

HIV-1

Keywords

HIV-1

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Limb Fat at Week 48

  Limb fat was measured by DEXA. Change = Week 48 value minus baseline value.

  Baseline to Week 48

Secondary Outcomes (17)

• Change From Baseline in the Mitochondrial DNA/Nuclear DNA Ratio (Oral Mucosa)

  Baseline to Week 48

• Change From Baseline in the Mitochondrial DNA/Nuclear DNA Ratio (Lymphocytes)

  Baseline to Week 48

• Change From Baseline in Lactate Concentration

  Baseline to Week 48

• Percentage of Days for Which Participants Were Compliant With Study Drug

  Baseline to Week 72

• Percentage of Participants Who Maintain Confirmed HIV-1 RNA < 50 Copies/mL

  48 weeks

Study Arms (2)

Truvada

EXPERIMENTAL

Truvada + NNRTI or PI.

Drug: Truvada

Zidovudine/lamivudine

ACTIVE COMPARATOR

Zidovudine/lamivudine + NNRTI or PI.

Drug: Zidovudine/lamivudine

Interventions

Truvada DRUG

Truvada once daily with continuation of the current NNRTI or PI at randomization.

Truvada

Zidovudine/lamivudine DRUG

Continuation of the zidovudine + lamivudine containing regimen plus the current NNRTI or PI at randomization.

Zidovudine/lamivudine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV-1 infection documented by confirmed positive HIV-1 antibody test and/or positive polymerase chain reaction for HIV-1 ribonucleic acid (RNA).
• Adult patients (over 18 years of age).
• Current HAART regimen containing zidovudine + lamivudine at usual doses for at least 6 months.
• Viral load \< 50 copies/mL on the last two consecutive determinations, under zidovudine + lamivudine 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 were allowed to participate in the study only if the lipid-lowering treatment (either statins or fibrates) was stable for at least 8 weeks prior to screening and it was not expected to change during the first 3 months of the study.

You may not qualify if:

• Patients on current FTC or TDF therapy.
• Patients with previous history of virological failure on an FTC or TDF-containing regimen.
• Patients receiving a non-registered antiretroviral drug.
• Patients receiving a triple-nucleoside antiretroviral combination.
• Hypersensitivity to one of the components of the dosage forms of TDF or FTC, or previous history of intolerance to one of those drugs.
• Known history of drug abuse or chronic alcohol consumption
• Women who were pregnant or breast feeding, or female of childbearing potential who did not use an adequate method of contraception according to the investigator's judgment.
• 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 or chemotherapy.
• Patients who were not to be included in the study according to the investigator's criterion.

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (1)

Gilead Sciences, S.L.

Madrid, E-28036, Spain

Location

MeSH Terms

Interventions

Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; lamivudine, zidovudine drug combination

Intervention Hierarchy (Ancestors)

Tenofovir; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Emtricitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Drug Combinations; Pharmaceutical Preparations

Results Point of Contact

• Title: Pedro Ferrer
• Organization: Gilead Sciences

pedro.ferrer@gilead.com

+34 91 771 2478

Study Officials

• Pedro Ferrer

  Gilead Sciences, S.L.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2006
• First Posted: May 11, 2006
• Study Start: May 1, 2006
• Primary Completion: March 1, 2008
• Study Completion: September 1, 2008
• Last Updated: August 17, 2015
• Results First Posted: May 20, 2009

Record last verified: 2015-08

Locations

ES (1)