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OpenTrials
Completed

NCT Number: NCT01274780

Metabolic Effects of Atazanavir/Ritonavir Versus Darunavir/Ritonavir in Combination With Tenofovir/Emtricitabine in naïve HIV-1 Infected Patients

This is a prospective, open controlled trial in which naïve HIV-1 patients will be randomized to receive atazanavir / ritonavir or darunavir / ritonavir in combination with tenofovir / emtricitabine. They will be followed up during 96 weeks to determinate the cholesterol levels.

Randomization will be stratified according to the values of the ratio of total cholesterol/HDL cholesterol obtained during the screening visit (as they will be <4.5 or ≥ 4.5).

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Key information

Conditions

HIV-1

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Clinic

Barcelona, 08036, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients of both sexes aged 18 years or more. Women of childbearing potential must commit to sexual abstinence or use barrier contraceptive methods during the study.
  • Diagnosis of infection by HIV-1 (according to standard diagnostic criteria)
  • Not previously treated with antiretroviral drugs
  • Plasma viral load > = 1000 copies / ml
  • Clinically stable patients in the investigator's opinion at the time of inclusion
  • Able to meet the schedule of study visits and other protocol requirements
  • Written informed consent to participate in the study and undergo tests and examinations that entails

Exclusion criteria

  • ALT, AST levels greater than or equal to 5 times ULN (upper limit of normal)
  • serum creatinine level greater than 2 times ULN
  • Diabetes Mellitus (according to clinical and / or use of anti-diabetic agents)
  • Obesity (BMI ≥ 30 kg/m2)
  • Use of drugs that may affect lipid and / or glucose metabolism for at least 30 days prior to inclusion in the study.
  • Active opportunistic infection requiring intravenous treatment
  • Patients with known hypersensitivity to any of the products under study
  • Use of drugs formally contraindicated in the product information for any of the drugs under study
  • Contraindication to the use of any of the drugs under study
  • Women pregnant or lactating at the time of study inclusion or anticipating pregnancy in the follow-up period provided by the test

Treatment and study plan

Darunavir / Ritonavir + Tenofovir / Emtricitabine

Drug

oral, 800/100 mg, qd + oral, 300/200 mg, qd

Atazanavir / Ritonavir + Tenofovir / Emtricitabine

Drug

oral, 300/100 mg, qd + oral, 300/200 mg, qd

Primary outcomes

  1. Changes in total cholesterol

    Time frame: 24 weeks

Secondary outcomes

  1. Blood levels of: triglycerides, total cholesterol, LDL cholesterol, HDL cholesterol and ratio of total cholesterol/HDL cholesterol

    Time frame: 24, 48 and 96 weeks

  2. Cardiovascular risk according to the Framingham scale.

    Time frame: 24, 48 and 96 weeks.

  3. Glycemic profile (including glucose, insulin and HOMA (homeostatic model assessment index))

    Time frame: 24, 48 and 96 weeks

  4. inflammatory markers (protein C-reactive protein and interleukin-6) and anti-inflammatory (adiponectin)

    Time frame: 24, 48 and 96 weeks

  5. RNA viral load <50 copies / mL

    Time frame: 24, 48 and 96 weeks.

  6. CD4+ cells count

    Time frame: 24, 48 and 96 weeks

  7. clinical adverse events, including events related to depositional patterns, laboratory abnormalities and incidence of treatment discontinuation because of toxicity or intolerance in each of the treatment arms.

    Time frame: 24, 48 and 96 weeks

  8. distribution of body fat by DEXA (X-ray densitometry dual energy level) and CT (Computerized Axial Tomography)scan

    Time frame: 48 and 96 weeks

Sponsors and collaborators

Lead sponsor

Juan A. Arnaiz

Other

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Jan 12, 2011
Registry last updated
Dec 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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