NCT00379405

Brief Summary

Study the efficacy of Saquinavir/Ritonavir when given in single therapy as maintenance therapy, compared to standard HAART therapies.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_4 hiv-infections

Timeline
Completed

Started Jun 2006

Geographic Reach
1 country

2 active sites

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

June 1, 2006

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 20, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 21, 2006

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

December 4, 2019

Status Verified

December 1, 2019

Enrollment Period

1.9 years

First QC Date

September 20, 2006

Last Update Submit

December 3, 2019

Conditions

HIV Infections

Keywords

Saquinavir/ritonavirSingle therapyVirological efficacySafetyHIV-1

Outcome Measures

Primary Outcomes (1)

  • Virological response: Viral Load

    weeks 24 and 48

Secondary Outcomes (10)

  • CD4 and CD8 lymphocyte count.

    weeks 24 and 48

  • Physical Exploration: including weight, height, index waist/hip (the abdominal perimeter is measured between the last floating rib and the iliac crest), assessment of changes in body fat distribution,...

    weeks 24 and 48

  • Karnofsky Index.

    weeks 24 and 48

  • Adverse events.

    during the 48 weeks of follow-up

  • Trough plasma concentrations of Saquinavir.

    during the 48 weeks of follow-up

  • +5 more secondary outcomes

Study Arms (2)

A

EXPERIMENTAL

Saquinavir (Invirase): 2 capsules (500 mg) / 12 hours

Drug: Saquinavir/Ritonavir : 2 capsules (500 mg) / 12 hours

2

NO INTERVENTION

IP o NNUCS + 2 NUCS as a HAART therapy .

Interventions

Saquinavir/Ritonavir : 2 capsules (500 mg) / 12 hoursDRUG

Saquinavir/Ritonavir: 2 capsules (500 mg) / 12 hours

Also known as: Invirase
A

Eligibility Criteria

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

You may qualify if:

  • Patients infected by HIV-1 (at least one documented positive Western-Blot).
  • Age \> 18 years.
  • Patients on antiretroviral treatment (standard HAART therapy) for at least six months.
  • Patients without evidence of previous virological failure to IP
  • Subject able to follow the treatment period, without any suspicion of poor adherence during previous antiretroviral treatments.
  • Signature of the informed consent.

You may not qualify if:

  • Suspicion of unsuitable antiretroviral treatment compliance.
  • Documented existence of any of the primary mutations in the protease gene or 3 or more of the following: L10F/I/R/V, K20M/R, M36I/V, I54L/T/V, L63P, A71T/V , V82A/F/T/S, I84A/V OR L90M.
  • Known allergic hypersensitivity to any of the investigational drugs or any similar drug.
  • Hepatic tests (AST, ALT, GGT) \> or equal to 5 times the upper limit of normality during the three months prior to the screening visit
  • Presence of renal impairment (creatinine \> or equal to 1.5 times the upper limit of normality).
  • Pregnancy or breastfeeding. Refusal to use reliable contraceptive methods during the study period.
  • Participation in another clinical trial wich entail the antiretroviral treatment modification.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Germans Trias i Pujol University Hospital

Badalona, Barcelona, 08916, Spain

Location

Hospital del Sant Pau.

Barcelona, 08025, Spain

Location

MeSH Terms

Conditions

HIV Infections

Interventions

SaquinavirRitonavir

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

IsoquinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsQuinolinesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-Ring

Study Officials

  • Clotet Bonaventura, MD,PhD

    Hospital Universitari Germans Trias i Pujol. Badalona (Barcelona)

    PRINCIPAL INVESTIGATOR

  • Negredo Eugenia, MD,PhD

    Hospital Universitari Germans Trias i Pujol. Badalona. (Barcelona)

    PRINCIPAL INVESTIGATOR

  • Echeverria Patricia, MD,PhD

    Hospital Universitari Germans Trias i Pujol. Badalona. (Barcelona)

    PRINCIPAL INVESTIGATOR

  • Molto Jose, MD,PhD

    Hospital Universitari Germans Trias i Pujol. Badalona. (Barcelona)

    PRINCIPAL INVESTIGATOR

  • Pere Domingo, MD, PhD

    Hospital de Sant Pau

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2006

First Posted

September 21, 2006

Study Start

June 1, 2006

Primary Completion

May 1, 2008

Study Completion

July 1, 2008

Last Updated

December 4, 2019

Record last verified: 2019-12

Locations

ES(2)