Phase 4 N=80 Randomized Treatment

Peripheral Body Fat Distribution After Switching Zidovudine and Lamivudine to Truvada

HIV-1

Bottom Line

View on ClinicalTrials.gov: NCT00324649 ↗

Enrolled (actual)

Serious AEs

—

Results posted

May 2009

Primary outcome: Primary: Change From Baseline in Limb Fat at Week 48 — 392; -257 grams (g) — p=0.0014

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Truvada (Drug); Zidovudine/lamivudine (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Gilead Sciences
Primary completion: Mar 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Limb Fat at Week 48	392; -257	0.0014 sig
SECONDARY Change From Baseline in the Mitochondrial DNA/Nuclear DNA Ratio (Oral Mucosa)	62.0; 97.0	0.9713
SECONDARY Change From Baseline in the Mitochondrial DNA/Nuclear DNA Ratio (Lymphocytes)	36.0; 43.0	0.9725
SECONDARY Change From Baseline in Lactate Concentration	-0.23; 0.09	0.0078 sig
SECONDARY Percentage of Days for Which Participants Were Compliant With Study Drug	100.0; 100.0	0.6984
SECONDARY Percentage of Participants Who Maintain Confirmed HIV-1 RNA < 50 Copies/mL	92.3; 78.0	0.1165
SECONDARY Percentage of Participants With HIV-1 RNA > 50 and < 400 Copies/mL	0; 5	—
SECONDARY Percentage of Participants With Virologic Failure	0; 0	—
SECONDARY Change From Baseline in Cluster Determinant 4 (CD4) Cell Count	60.5; 9.0	0.0789
SECONDARY Change From Baseline in Fasting Serum Triglycerides	1.5; 4.0	0.9633
SECONDARY Change From Baseline in Fasting Total Cholesterol	4.5; 1.0	0.9686
SECONDARY Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL)	7.0; 5.0	0.6638
SECONDARY Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL)	-2.0; 2.0	0.2907
SECONDARY Change From Baseline in Hemoglobin	0.9; 0.3	0.0072 sig
SECONDARY Percent Change From Baseline in Hematocrit	2.7; 1.0	0.0006 sig
SECONDARY Change From Baseline in Waist Circumference/Hip Circumference Ratio	-0.01; 0.01	0.1785
SECONDARY Percentage of Participants With Any Adverse Event	77; 85	—
SECONDARY Percentage of Participants Who Discontinue the Study Prematurely (Before Week 48) Due to Adverse Events.	3; 10	—

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).

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

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.

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Data sourced from ClinicalTrials.gov (NCT00324649). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.