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ROCKET I - Randomized Open Label Switch for Cholesterol Elevation on Kivexa Evaluation Trial

NCT00615810 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 159

Last updated 2010-08-02

No results posted yet for this study

Summary

This study aims to investigate whether patients switching their backbone from Kivexa to Truvada, who already have raised total cholesterol prior to switching, have an improvement in their total cholesterol after 12 weeks of treatment. If an improvement is demonstrated the study aims to show whether this has a beneficial effect on the patient's overall cardiovascular risk and long term prognosis.

Conditions

  • HIV Infections

Interventions

DRUG

Atripla

Open label once daily for oral administration to be taken on an empty stomach

DRUG

Kivexa plus Sustiva

Open label once daily for oral administration

Sponsors & Collaborators

Principal Investigators

  • Cham Herath · Gilead Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2009-10-31
Completion
2010-01-31

Countries

  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00615810 on ClinicalTrials.gov