Peripheral Body Fat Distribution After Switching Zidovudine and Lamivudine to Truvada - Study Results

Study Type:	Interventional
Study Design:	Randomized, Open Label, Active Control, Parallel Assignment
Condition:	HIV-1
Interventions:	Drug: Truvada Drug: Zidovudine/lamivudine

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Truvada	Truvada + nonnucleoside reverse transcriptase inhibitor (NNRTI) or protease inhibitor (PI).
Zidovudine/Lamivudine	Zidovudine/lamivudine + nonnucleoside reverse transcriptase inhibitor (NNRTI) or protease inhibitor (PI).

Participant Flow: Overall Study

	Truvada	Zidovudine/Lamivudine
STARTED	39	41
COMPLETED	37	36
NOT COMPLETED	2	5
Adverse Event	1	4
Withdrawal by Subject	0	1
Noncompliance	1	0

Baseline Characteristics

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Reporting Groups

	Description
Truvada	Truvada + NNRTI or PI.
Zidovudine/Lamivudine	Zidovudine/lamivudine + NNRTI or PI.

Baseline Measures

	Truvada	Zidovudine/Lamivudine	Total
Number of Participants [units: participants]	39	41	80
Age [units: years] Mean ± Standard Deviation	44 ± 10.6	44 ± 7.4	44 ± 9.0
Gender [units: participants]
Female	11	4	15
Male	28	37	65
Race/Ethnicity, Customized [units: Participants]
White	36	38	74
Black, of African heritage	1	2	3
Asian	1	0	1
Other	1	1	2
Region of Enrollment [units: participants]
Spain	39	41	80
HIV-1 RNA Level [units: Participants]
< 50 copies/mL	38	39	77
50 to < 400 copies/mL	1	2	3
Cluster determinant 4 (CD4) cell count [units: cells/mm^3] Median ( Inter-Quartile Range )	655.0 ( 505.0 to 789.0 )	504.0 ( 363.0 to 756.0 )	600.5 ( 420.0 to 760.5 )
Total limb fat^[1] [units: grams (g)] Median ( Full Range )	3565 ( 511 to 15932 )	3589 ( 903 to 28155 )	3589 ( 511 to 28155 )
Years on AZT/3TC [units: Years] Median ( Inter-Quartile Range )	5.8 ( 4.2 to 7.2 )	6.2 ( 4.7 to 7.2 )	5.9 ( 4.6 to 7.2 )

[1]	Measured using DEXA. Total limb fat is the sum of the left arm, right arm, left leg, and right leg.

Outcome Measures

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1. Primary:

Change From Baseline in Limb Fat at Week 48 [ Baseline to Week 48 ]

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2. Secondary:

Change From Baseline in the Mitochondrial DNA/Nuclear DNA Ratio (Oral Mucosa) [ Baseline to Week 48 ]

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3. Secondary:

Change From Baseline in the Mitochondrial DNA/Nuclear DNA Ratio (Lymphocytes) [ Baseline to Week 48 ]

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4. Secondary:

Change From Baseline in Lactate Concentration [ Baseline to Week 48 ]

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5. Secondary:

Percentage of Days for Which Participants Were Compliant With Study Drug [ Baseline to Week 72 ]

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6. Secondary:

Percentage of Participants Who Maintain Confirmed HIV-1 RNA < 50 Copies/mL [ 48 weeks ]

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7. Secondary:

Percentage of Participants With HIV-1 RNA > 50 and < 400 Copies/mL [ 48 weeks ]

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8. Secondary:

Percentage of Participants With Virologic Failure [ 48 weeks ]

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9. Secondary:

Change From Baseline in Cluster Determinant 4 (CD4) Cell Count [ Baseline to Week 48 ]

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10. Secondary:

Change From Baseline in Fasting Serum Triglycerides [ Baseline to Week 48 ]

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11. Secondary:

Change From Baseline in Fasting Total Cholesterol [ Baseline to Week 48 ]

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12. Secondary:

Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL) [ Baseline to Week 48 ]

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13. Secondary:

Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL) [ Baseline to Week 48 ]

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14. Secondary:

Change From Baseline in Hemoglobin [ Baseline to Week 48 ]

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15. Secondary:

Change From Baseline in Hematocrit [ Baseline to Week 48 ]

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16. Secondary:

Change From Baseline in Waist Circumference/Hip Circumference Ratio [ Baseline to Week 48 ]

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17. Secondary:

Percentage of Participants With Any Adverse Event [ 72 weeks ]

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18. Secondary:

Percentage of Participants Who Discontinue the Study Prematurely (Before Week 48) Due to Adverse Events. [ 48 weeks ]

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Serious Adverse Events

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Other Adverse Events

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Time Frame	No text entered.
Additional Description	No text entered.

Frequency Threshold

Threshold above which other adverse events are reported	5%

Reporting Groups

	Description
Truvada	Truvada + NNRTI or PI.
Zidovudine/Lamivudine	Zidovudine/lamivudine + NNRTI or PI.

Other Adverse Events

	Truvada	Zidovudine/Lamivudine
Total, other (not including serious) adverse events
# participants affected	24	28
Blood and lymphatic system disorders
Anaemia ^†^A # participants affected / at risk	1/39 (2.56%)	3/41 (7.32%)
Neutropenia ^† # participants affected / at risk	0/39 (0.00%)	3/41 (7.32%)
Gastrointestinal disorders
Diarrhoea * # participants affected / at risk	3/39 (7.69%)	2/41 (4.88%)
Abdominal pain upper * # participants affected / at risk	2/39 (5.13%)	0/41 (0.00%)
General disorders
Pyrexia * # participants affected / at risk	2/39 (5.13%)	0/41 (0.00%)
Infections and infestations
Bronchitis * # participants affected / at risk	2/39 (5.13%)	0/41 (0.00%)
Investigations
Gamma-glutamyltransferase increased ^† # participants affected / at risk	11/39 (28.21%)	10/41 (24.39%)
Alanine aminotransferase increased ^† # participants affected / at risk	8/39 (20.51%)	10/41 (24.39%)
Aspartate aminotransferase increased ^† # participants affected / at risk	4/39 (10.26%)	6/41 (14.63%)
Blood amylase increased ^† # participants affected / at risk	4/39 (10.26%)	8/41 (19.51%)
Lipase increased ^† # participants affected / at risk	1/39 (2.56%)	3/41 (7.32%)
Blood creatine phosphokinase increased ^† # participants affected / at risk	3/39 (7.69%)	3/41 (7.32%)
Blood lactic acid increased ^† # participants affected / at risk	2/39 (5.13%)	4/41 (9.76%)
Metabolism and nutrition disorders
Hypercholesterolaemia ^† # participants affected / at risk	2/39 (5.13%)	4/41 (9.76%)
Hyperlactacidaemia ^† # participants affected / at risk	2/39 (5.13%)	0/41 (0.00%)
Musculoskeletal and connective tissue disorders
Back pain * # participants affected / at risk	1/39 (2.56%)	3/41 (7.32%)
Renal and urinary disorders
Renal colic * # participants affected / at risk	0/39 (0.00%)	3/41 (7.32%)

^†	Indicates events were collected by systematic assessment.
*	Indicates events were collected by non-systematic assessment.
^A	Term from vocabulary, MedDRA 11

More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Restriction Description:

After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other scholarly media only after the following conditions have been met:

The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or
The study has been completed at all study sites for at least 2 years.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Pedro Ferrer
Organization: Gilead Sciences
phone: +34 91 771 2478
e-mail: pedro.ferrer@gilead.com

No publications provided

Responsible Party:	Gilead Sciences ( Pedro Ferrer )
Study ID Numbers:	GS-ES-164-0154
Study First Received:	May 9, 2006
Results First Received:	March 30, 2009
Last Updated:	November 20, 2009
ClinicalTrials.gov Identifier:	NCT00324649 History of Changes
Health Authority:	Spain: Spanish Agency of Medicines