NCT00830804

Brief Summary

The purpose of this study is to assess the effectiveness and safety of an antiretroviral therapy (ART) regimen consisting of raltegravir (RAL) and darunavir (DRV)/ritonavir (RTV) as first-line therapy in treatment-naïve participants.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
113

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2009

Shorter than P25 for phase_2

Geographic Reach
1 country

22 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

First Submitted

Initial submission to the registry

January 26, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 28, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2009

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

October 10, 2011

Completed
Last Updated

November 8, 2018

Status Verified

October 1, 2018

Enrollment Period

10 months

First QC Date

January 26, 2009

Results QC Date

September 7, 2011

Last Update Submit

October 11, 2018

Conditions

HIV-1 Infections

Keywords

Treatment Naive

Outcome Measures

Primary Outcomes (1)

  • Proportion of Participants With Virologic Failure After Initiating RAL Plus DRV/RTV at or Prior to Week 24

    Virologic failure is defined as: at week 12, confirmed plasma HIV-1 RNA \>= 1000 copies/ml or confirmed rebound from the week 4 value by \>0.5 log10 copies/ml (for subjects with week 4 value \<= 50 copies/ml, confirmed rebound to \>50 copies/ml); at week 24 or later, confirmed value \> 50 copies/ml. Viral load confirmation was scheduled 7-35 days after initial virologic failure. The proportion was estimated using Kaplan-Meier method. An adaptation of Greenwood's variance estimate was used in constructing the confidence interval.

    From start of study treatment to week 24

Secondary Outcomes (16)

  • Proportion of Participants With Virologic Failure or Off Study Treatment Regimen or Death at or Prior to Week 24

    From start of study treatment to Week 24

  • Change in Plasma HIV-1 RNA From Baseline to Week 1

    Baseline and week 1

  • Proportion of Participants With Plasma HIV-1 RNA < 50 Copies/ml or <200 Copies/ml at Week 24

    From start of study treatment to week 24

  • Proportion of Participants With Plasma HIV-1 RNA <50 Copies/ml or <200 Copies/ml at Week 48

    From start of study treatment to week 48

  • Proportion of Participants Who Experienced Signs/Symptoms or Laboratory Toxicities Grade 3 or Higher, or of Any Grade Which Led to a Permanent Change or Discontinuation of Study Treatment

    From start of study treatment to week 52

  • +11 more secondary outcomes

Study Arms (1)

RAL + DRV/RTV

EXPERIMENTAL

Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks

Drug: RaltegravirDrug: Darunavir/Ritonavir

Interventions

RaltegravirDRUG

400 mg tablet taken orally twice daily

Also known as: RAL
RAL + DRV/RTV
Darunavir/RitonavirDRUG

800 mg Darunavir/100 mg Ritonavir tablet taken orally once daily

Also known as: DRV/RTV
RAL + DRV/RTV

Eligibility Criteria

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

You may qualify if:

  • HIV-1-infected
  • Plasma HIV-1 RNA of at least 5,000 copies/mL within 90 days prior to study entry
  • HIV genotype (for reverse transcriptase and protease) performed at any time prior to study entry. More information on this criterion can be found in the protocol.
  • ARV drug-naive. More information on this criterion can be found in the protocol.
  • Negative result from a hepatitis B surface antigen test performed within 90 days prior to study entry
  • Agree to use one form of medically-accepted contraceptive throughout the study and for 60 days after stopping study treatment. More information on this criterion can be found in the protocol.

You may not qualify if:

  • Serious illness requiring systemic treatment and/or hospitalization for at least 7 days prior to study. More information on this criterion can be found in the protocol.
  • Screening HIV genotype obtained any time prior to study entry with more than one DRV resistance-associated mutation \[RAM\] (V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, I84V, and L89V) or L76V alone
  • Known major integrase inhibitor RAM(s), including N155H, Q148H/R/K, Y143C/R, and G140S
  • Severe renal insufficiency requiring hemodialysis or peritoneal dialysis
  • Treatment with immunomodulators within 30 days prior to study entry. More information on this criterion can be found in the protocol.
  • Current medications that are prohibited with any study medications. More information on this criterion can be found in the protocol.
  • Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with the study.
  • Certain abnormal laboratory results. More information on this criterion can be found in the protocol.
  • Pregnant or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (22)

AlabamaTherapeutics CRS

Birmingham, Alabama, 35294, United States

Location

Stanford CRS

Palo Alto, California, 94304, United States

Location

Ucsd, Avrc Crs

San Diego, California, 92103, United States

Location

Ucsf Aids Crs

San Francisco, California, 94110, United States

Location

University of Colorado Hospital CRS

Aurora, Colorado, 80045, United States

Location

Georgetown University CRS

Washington D.C., District of Columbia, 20007, United States

Location

Northwestern University CRS

Chicago, Illinois, 60611, United States

Location

Beth Israel Deaconess Med Center

Boston, Massachusetts, 02115, United States

Location

Brigham and Women's Hosp. ACTG CRS

Boston, Massachusetts, 02115, United States

Location

Washington U CRS

St Louis, Missouri, 63110, United States

Location

AIDS Community Health Ctr. ACTG CRS

Rochester, New York, 14604, United States

Location

Unc Aids Crs

Chapel Hill, North Carolina, 27599, United States

Location

Duke Univ. Med. Ctr. Adult CRS

Durham, North Carolina, 27710, United States

Location

Univ. of Cincinnati CRS

Cincinnati, Ohio, 45267-0405, United States

Location

Case CRS

Cleveland, Ohio, 44106, United States

Location

MetroHealth CRS

Cleveland, Ohio, 44109, United States

Location

The Ohio State Univ. AIDS CRS

Columbus, Ohio, 43210, United States

Location

Hosp. of the Univ. of Pennsylvania CRS

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pittsburgh CTU

Pittsburgh, Pennsylvania, 15213, United States

Location

The Miriam Hospital

Providence, Rhode Island, 02906, United States

Location

Vanderbilt Therapeutics CRS

Nashville, Tennessee, 37203, United States

Location

Houston AIDS Research Team

Houston, Texas, 77030, United States

Location

Related Publications (4)

  • Capetti AF, Piconi S, Landonio S, Rizzardini G, Perno CF. Is dual therapy with raltegravir and protease inhibitors a feasible option in rescue strategy in HIV-1 infection? J Acquir Immune Defic Syndr. 2009 Feb 1;50(2):233-4. doi: 10.1097/QAI.0b013e31818c7e8e. No abstract available.

    PMID: 19155770BACKGROUND

  • Long MC, King JR, Acosta EP. Pharmacologic aspects of new antiretroviral drugs. Curr HIV/AIDS Rep. 2009 Feb;6(1):43-50. doi: 10.1007/s11904-009-0007-y.

    PMID: 19149996BACKGROUND

  • Vermeir M, Lachau-Durand S, Mannens G, Cuyckens F, van Hoof B, Raoof A. Absorption, metabolism, and excretion of darunavir, a new protease inhibitor, administered alone and with low-dose ritonavir in healthy subjects. Drug Metab Dispos. 2009 Apr;37(4):809-20. doi: 10.1124/dmd.108.024109. Epub 2009 Jan 8.

    PMID: 19131522BACKGROUND

  • Taiwo B, Zheng L, Gallien S, Matining RM, Kuritzkes DR, Wilson CC, Berzins BI, Acosta EP, Bastow B, Kim PS, Eron JJ Jr; ACTG A5262 Team. Efficacy of a nucleoside-sparing regimen of darunavir/ritonavir plus raltegravir in treatment-naive HIV-1-infected patients (ACTG A5262). AIDS. 2011 Nov 13;25(17):2113-22. doi: 10.1097/QAD.0b013e32834bbaa9.

    PMID: 21857490DERIVED

MeSH Terms

Interventions

Raltegravir PotassiumDarunavirRitonavir

Intervention Hierarchy (Ancestors)

PyrrolidinonesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsSulfonamidesAmidesOrganic ChemicalsCarbamatesAcids, AcyclicCarboxylic AcidsSulfonesSulfur CompoundsFuransThiazolesAzoles

Limitations and Caveats

This is a single-arm study.

Results Point of Contact

Title
ACTG ClinicalTrials.gov Coordinator
Organization
ACTG Network Coordinating Center, Social and Scientific Systems, Inc.
ACTGCT.Gov@s-3.com
(301) 628-3313

Study Officials

  • Joseph J. Eron, Jr., MD

    University of North Carolina, Chapel Hill

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2009

First Posted

January 28, 2009

Study Start

April 1, 2009

Primary Completion

February 1, 2010

Study Completion

September 1, 2010

Last Updated

November 8, 2018

Results First Posted

October 10, 2011

Record last verified: 2018-10

Locations

US(22)