NCT00751153

Brief Summary

Subjects with HIV who have viral suppression on current regimen but also have side effects/intolerance will change their current regimen to a combination of Raltegravir and Atazanavir and be monitored for viral and immunological response and quality of life.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_4 hiv-infections

Timeline
Completed

Started Mar 2008

Shorter than P25 for phase_4 hiv-infections

Geographic Reach
1 country

1 active site

Status
unknown

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

March 1, 2008

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 10, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 11, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

October 9, 2008

Status Verified

September 1, 2008

Enrollment Period

1.6 years

First QC Date

September 10, 2008

Last Update Submit

October 8, 2008

Conditions

HIV Infections

Keywords

drug substitutionRaltegravirAtazanavirtreatment Experienced

Outcome Measures

Primary Outcomes (1)

  • Evaluation of the proportion of patients who maintain plasma HIV viral load measurements < 400 copies/ml at week 4, 8, 12, 16, 24, 36 and 48 weeks after switching to Raltegravir and Atazanavir

    48 weeks

Secondary Outcomes (6)

  • Evaluation of the proportion of patients who have plasma HIV viral load measurements <50 copies/ml at week 4, 8, 12, 16, 24, 36 and 48 weeks after switching to Raltegravir and Atazanavir

    48 weeks

  • Time to virologic failure (defined as 2 consecutive VL measurements > 400 copies/ml on 2 separate clinic visits within 4 weeks)

    48 weeks

  • Assessment of CD4 cell count changes at 4, 8, 12, 16, 24, 36 and 48 weeks after switching to Raltegravir and Atazanavir

    48 weeks

  • Assessment of lipid changes after change in regimen

    48 weeks

  • Determination of incidence, genotypic and phenotypic resistance patterns, in particular to Raltegravir and Atazanavir, in patients in the event of rebound viremia

    48 weeks

  • +1 more secondary outcomes

Interventions

Raltegravir and AtazanavirDRUG

Rategravir 400 BID, Atazanavir 400 mg daily

Eligibility Criteria

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

You may qualify if:

  • History of no PI resistance or antiretroviral failure while receiving a PI.
  • On a current antiviral regimen with plasma HIV viral load (VL) \< 400 copies/ml for 4 months or longer.
  • Intolerance to or toxicity with current or alternative regimen(s) with side effects including but not limited to gastrointestinal, neurological, metabolic, or dysmorphic symptoms and/or dyslipidemia.
  • Continuously using the same regimen for 3 months prior to Screening.
  • Women of childbearing potential must be willing to use effective method(s) of contraception throughout their study participation and for 30 days following the end of the study (see Section 1.10). -Women who are postmenopausal for at least 2 years, women with total hysterectomy and women with tubal ligation are considered of non-childbearing potential.
  • Willing to adhere to the prohibitions and restrictions specified in this protocol.

You may not qualify if:

  • Use of any drug contraindicated in the current US package insert for Atazanavir or in the investigators brochure for Raltegravir, including PPI inhibitors.
  • Use of any investigational drug up to 4 weeks prior to screening.
  • Prior or current therapy with Raltegravir.
  • Allergy to Raltegravir or Atazanavir
  • History of medication non-compliance significant to the study regimen as deemed significant by the investigator.
  • Known achlorhydria that would inhibit the absorption of Atazanavir
  • Concurrent active chronic Hepatitis B requiring therapy with 3TC, FTC or Tenofovir (entecavir permitted).
  • AST or ALT \>5 times ULN
  • Calculated CrCl \< 30 ml/min.
  • Female subject who is pregnant or breastfeeding.
  • General medical condition that may interfere with the assessments and completion of the trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Practice of Peter Ruane MB

Los Angeles, California, 90036, United States

RECRUITING

MeSH Terms

Conditions

HIV Infections

Interventions

Raltegravir PotassiumAtazanavir Sulfate

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)

PyrrolidinonesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyridinesOligopeptidesPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Peter J Ruane, MB

    Peter J Ruane MD Inc

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter J Ruane, MB

CONTACT

3239541072pjruane@lightsourcemedical.com

Brian Alas

CONTACT

3239541072balas@lightsourcemedical.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 10, 2008

First Posted

September 11, 2008

Study Start

March 1, 2008

Primary Completion

October 1, 2009

Study Completion

December 1, 2009

Last Updated

October 9, 2008

Record last verified: 2008-09

Locations

US(1)