Peripheral Body Fat Distribution After Switching Zidovudine and Lamivudine to Truvada

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00324649
• Date of registration: 09/05/2006
• Prospective Registration: No
• Primary sponsor: Gilead Sciences
• Public title: Peripheral Body Fat Distribution After Switching Zidovudine and Lamivudine to Truvada RECOMB
• Scientific title: 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 HAART (RECOMB Study).
• Date of first enrolment: May 2006
• Target sample size: 80
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00324649
• Study type: Interventional
• Phase: Phase 4

Countries of recruitment

Spain

Contacts

• Name: Pedro Ferrer
• Affiliation: Gilead Sciences, S.L.

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

HIV-1

Intervention(s)

Drug: Truvada

Drug: Zidovudine/lamivudine

Primary Outcome(s)

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

Secondary Outcome(s)

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

Change From Baseline in Lactate Concentration [Time Frame: Baseline to Week 48]

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

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

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

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

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

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

Percentage of Participants With Virologic Failure [Time Frame: 48 weeks]

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

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

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

Percentage of Participants With Any Adverse Event [Time Frame: 72 weeks]

Percent Change From Baseline in Hematocrit [Time Frame: Baseline to Week 48]

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

Change From Baseline in Hemoglobin [Time Frame: Baseline to Week 48]

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

Secondary ID(s)

GS-ES-164-0154

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 20/05/2009
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00324649