NCT00192608

Brief Summary

Saquinavir and Atazanavir are drugs used in combination therapy to treat HIV disease. Saquinavir is currently available in a 200 milligram capsule. Most individuals currently on saquinavir require to take 5 tablets twice a day. In an attempt to reduce this number of pills, a new capsule has been developed containing 500 milligrams of saquinavir. This study will assess: i) blood drug levels in individuals taking both saquinavir formulations, ii) blood drug levels in individuals taking both saquinavir formulations when given with atazanavir, iii) 48 weeks of follow up for individuals receiving the new saquinavir formulation with atazanavir as HIV therapy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at below P25 for not_applicable hiv-infections

Timeline
Completed

Started Nov 2004

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2004

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
Last Updated

June 26, 2009

Status Verified

June 1, 2009

Enrollment Period

1.5 years

First QC Date

September 13, 2005

Last Update Submit

June 25, 2009

Conditions

HIV Infections

Keywords

Pharmacokinetics, atazanavir, saquinavir, ritonavir, HIV

Outcome Measures

Primary Outcomes (4)

  • To compare the pharmacokinectic profile of ATV-SQV-RTV using SQV 500 and 200 formulations.

    week 48

  • To compare the pharmacokinetic profile of SQV/r 1000/100mg bid using SQV 500 and 200 formulations.

    week 48

  • To assess the durability and safety of a once daily double boosted PI regimen comprised of ATV300 - SQV1500 - RTV100

    week 48

  • To assess the decay pharmacokinetics

    week 48

Secondary Outcomes (4)

  • Assessment of adherence to medications.

    week 48

  • Assessment of changes to CD4 lymphocyte count

    week 48

  • Assessment of changes in lipid parameters

    week 48

  • Assessment of changes in monocyte mRNA

    week 48

Study Arms (2)

saquinavir at baseline

EXPERIMENTAL

patients receiving NRTIs + saquinavir + ritonavir 1000/100 mg BID at entry switch from 200 mg SQV capsules to 500 mg SQV tablets following PK at day 0. After PK at day 8 NRTIs ceased and regimen changed to ATV/SQV/RTV 300/1500/100 QD using 500 mg SQV formulation and continued to week 48

Drug: saquinavir 500 formulation

other boosted PI at baseline

EXPERIMENTAL

Patients receiving NRTIs + PI/RTV randomised at baseline to receive ATV/SQVRTV 300/1500/100 QD using 500 mg SQV formulation or ATV/SQV/RTV 300/1600/100 QD using 200 mg formulation. Following PK at day 7, SQV formulation switched with second PK assessment at day 15. Patients then receive ATV/SQV/RTV 300/1500/100 QD to week 48.

Drug: cross-over arm

Interventions

saquinavir 500 formulationDRUG

NRTIs + SQV/RTV 1000/100 mg BID using 200 mg SQV capsules switched at entry to ATV/SQV/RTV 300/1500/100 mg QD using 500 mg SQV tablet for 48 weeks with PK at days 0 and 8.

saquinavir at baseline
cross-over armDRUG

either ATV/SQV/RTV 300/1500/100 QD (500 mg SQV tabs) for 7 days then after PK SQV changed to 1600 mg QD (200 mg caps) with PK day 15, or ATV/SQV/RTV 300/1600/100 QD for 7 days with switch to SQV 1500 mg QD. After day 15 PK both groups switch to ATV/SQV/RTV 300/1500/100 QD to week 48

other boosted PI at baseline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • HIV-1 infected individuals aged 18 years or over On stable antiretroviral therapy for at least three months consisting of nucleoside reverse transcriptase inhibitors and protease inhibitors OR On stable antiretroviral therapy for at least three months consisting of atazanavir-saquinavir-ritonavir Undetectable HIV RNA viral load for past three months

You may not qualify if:

  • Individuals receiving on non-nucleoside reverse transcriptase inhibitors within the past three months
  • Individuals currently receiving other enzyme inducing agents (as per
  • Individuals receiving ritonavir at doses greater than 100 mg bid
  • Active AIDS defining illnesses
  • Previously documented intolerance or virological failure to saquinavir
  • Previously documented intolerance or virological failure to atazanavir
  • Patients who are co-infected with Hepatitis B and are likely to require, in their clinician's opinion, HBV nucleoside therapy during the study.
  • Female patients who are pregnant, breastfeeding, or who plan to become pregnant during the study
  • Any current clinical or laboratory parameter of ACTG Grade 4 (except lipids \& CK)
  • Evidence of ongoing alcohol and/or drug or substance abuse that would result in the patient being unreliable in fulfilling the conditions of this protocol
  • Prior non-adherence to antiretroviral treatment regimens that would result in the patient being unreliable in fulfilling the conditions of this protocol
  • Evidence of active opportunistic infection, intercurrent illness, drug toxicity or any other condition that would preclude the patient from taking the prescribed antiretroviral regimen
  • Conditions that might interfere with evaluation of the disease under study.
  • Conditions/allergies that may compromise the safety of the patient.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Vincents Hospital

Sydney, New South Wales, 2010, Australia

Location

Related Publications (1)

  • Winston A, Mallon PW, Satchell C, MacRae K, Williams KM, Schutz M, Law M, Cooper DA, Emery S. The safety, efficacy, and pharmacokinetic profile of a switch in antiretroviral therapy to saquinavir, ritonavir, and atazanavir alone for 48 weeks and a switch in the saquinavir formulation. Clin Infect Dis. 2007 Jun 1;44(11):1475-83. doi: 10.1086/517507. Epub 2007 Apr 18.

    PMID: 17479946RESULT

Related Links

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • David A Cooper, MD

    Kirby Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 19, 2005

Study Start

November 1, 2004

Primary Completion

May 1, 2006

Study Completion

May 1, 2006

Last Updated

June 26, 2009

Record last verified: 2009-06

Locations

AU(1)