Trials Sponsors Conditions Drugs Pricing

Conditions

HIV Infections

Keywords

lipidslipodystrophyfat distributionhiv-1antiretroviral therapyTreatment Naive

Outcome Measures

Primary Outcomes (1)

To assess the differences in changes in plasma lipids after once-daily saquinavir/ritonavir (2000/100 mg) or atazanavir/ritonavir (300/100 mg) each in combination with tenofovir disoproxil fumarate (300 mg QD) and emtricitabine (200 mg QD) for 24 weeks

Secondary Outcomes (6)

To assess the differences in changes in plasma lipids after once-daily saquinavir/ritonavir (2000/100 mg QD) or atazanavir/ritonavir (300/100 mg QD) each in combination with tenofovir disoproxil fumarate and emtricitabine for 48 weeks.
To compare differences in changes in glucose metabolism.
To compare changes in fat redistribution in both study arms.
To relate differences in changes in lipids, glucose metabolism and abdominal fat distribution to the plasma exposure of the different protease inhibitors (including ritonavir) used in the trial.
To assess the change in estimated glomerular filtration rate (GFR) by Cockcroft-Gault, MDRD and cystatin C-derived equations in both study arms.
+1 more secondary outcomes

Interventions

saquinavir/ritonavirDrug

atazanavir/ritonavirDrug

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Grouped treatment entry
saquinavir/ritonavir
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry record
Grouped treatment entry
atazanavir/ritonavir
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry record

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Providing written informed consent
HIV-1 infected patients.

Sponsors & Collaborators

International Antiviral Therapy Evaluation Center
Otherlead
Gilead Sciences
Industrycollaborator
Hoffmann-La Roche

Study Sites (1)

Academic Medical Centre, University of Amsterdam

Amsterdam, 1105 AZ, Netherlands

MeSH Terms

Conditions

HIV InfectionsLipodystrophyAcquired Immunodeficiency Syndrome

Interventions

SaquinavirRitonaviratazanavir, ritonavir drug combination

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus Infections

Study Officials

Peter Reiss, MD, PhD
Academic Medical Centre, University of Amsterdam, the Netherlands
STUDY CHAIR

Study Design

Study Type: interventional
Phase: phase 4
Allocation: RANDOMIZED
Masking: NONE
Purpose: PREVENTION
Intervention Model: PARALLEL
Sponsor Type: OTHER

Study Record Dates

First Submitted

October 17, 2006

First Posted

October 18, 2006

Study Start

July 2006

Date type not reported

This date has not been verified as actual or estimated.

Study Completion

July 2008

Actual (reported)

You may not qualify if:

CD4 count \> 350 cells/mm3, except in case of symptomatic HIV disease and/or an AIDS-defining illness.
HIV-2 co infection.
Use of co-medication with a known pharmacological interaction which precludes the appropriate use of one or more of the study drugs.
Anticipated non-compliance with the protocol.
Presence of a newly (within 30 days prior to the time of enrolment) diagnosed HIV-related opportunistic infection or condition which may interfere with the ability to comply with the study.
Chronic active viral hepatitis or other chronic liver disease, which in the opinion of the investigator is a contraindication for the use of any of the study drugs. Patients who may be considered to have active HBV replication (HBV-surface antigen positive and/or HBV-DNA positive) may be excluded in case the investigator feels that the benefit of starting tenofovir/emtricitabine does not outweigh the risk of a "hepatitis flare" in case tenofovir/emtricitabine would need to be prematurely discontinued for any reason during the trial. Chronic hepatitis C is allowed, provided that treatment for hepatitis C is not anticipated during the study period.
Women who are pregnant, or have the intention to become pregnant during the study period.
Clinically relevant laboratory abnormalities: anaemia, thrombocytopenia, leucopenia, elevated liver transaminases, elevated bilirubin, elevated amylase, elevated lipase, which in the opinion of the investigator is a contraindication for the use of any of the study drugs, or any current known clinical or laboratory parameter of ACTG Grade 4 (see Appendix 2). However, asymptomatic Grade 4 abnormalities will be permitted at the discretion of the investigator if deemed clinically appropriate. Abnormalities deemed insignificant by the investigator must be discussed with the sponsor prior to enrolment.
Significant renal dysfunction (creatinine clearance \[CrCl\] \<60 mL/min) and/or hepatic impairment (aspartate aminotransferase/alanine aminotransferase \[AST/ALT\] \>3 X ULN and/or documented liver cirrhosis)
Note: The site will calculate each patient's CrCl using the Cockcroft-Gault formula as shown below:
CrCl = \[140 - age (yr)\] × weight (kg) × constant 72 × serum creatinine (Cr) (mg/dL) where, constant = 1 for men and 0.85 for women.
Use of nephrotoxic agents which in the opinion of the investigator are a contraindication for the use of tenofovir disoproxil fumarate and any other of the study drugs.
Patients who have received within 4 weeks prior to entry, or who have an anticipated need for treatment with radiation therapy or cytotoxic chemotherapeutic agents during the protocol study period.
Patients who have taken any investigational drug 30 days prior to the start of the study.

BASIC: Boosted Atazanavir or Saquinavir Induced Lipid Changes

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations