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HIV InfectionsPhase 2NCT00071097

TMC114-C202: A Study of Safety, Efficacy, and Tolerability of TMC114 and Low Dose Ritonavir in HIV-1 Infected Patients

A Phase 2 study testing TMC114/rtv in people with HIV Infections, run by Tibotec Pharmaceuticals, Ireland at 39 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine the effectiveness, safety, and tolerability (how well the body stands the drug) of an investigational protease inhibitor (PI) called TMC114 given with low dose ritonavir. Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
HIV Infections
What is being tested?
TMC114/rtv
Could I receive a placebo?
No, everyone receives an active treatment
How many people
330 participants
Where
39 sitesin 2 countries
Study dates
Oct 2003to Nov 2007
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female, age 18 years or older
  • Documented HIV-1 infection
  • Stable PI regimen for at least 8 weeks prior to screening
  • Plasma viral load at screening above 1000 HIV-1 RNA copies/ml
  • Prior use of more than 1 NRTI for at least 3 months
  • Prior use of one or more NNRTIs as part of a failing regimen
Show all 9Show fewer
  • At least 1 primary PI mutation as defined by the IAS guidelines
  • Treatment with at least 1 PI for a total of at least 3 months
  • Patient has given informed consent

Who cannot join

  • Presence of any currently active AIDS defining illness except stable cutaneous Kaposi's Sarcoma and Wasting syndrome due to HIV infection
  • Current or past history of alcohol and/or drug abuse which, in the investigator's opinion, would compromise the subject's safety or compliance to the study protocol procedures
  • NNRTI as part of therapy at screening
  • Patients on a treatment interruption at screening
  • Patients for whom an investigational antiretroviral therapy is part of the regimen at screening or the use of any non-antiretroviral investigational agents 90 days prior to screening
  • Hepatitis A, B, or C.

Trial locations and contacts

39 sites in 2 countries.

39 sites in 2 countries

United States38 sites

  • Study site

    Albany, New York

  • Study site

    Altamonte Springs, Florida

  • Study site

    Atlanta, Georgia

  • Study site

    Baltimore, Maryland

  • Study site

    Beverly Hills, California

  • Study site

    Birmingham, Alabama

  • Study site

    Boston, Massachusetts

  • Study site

    Camden, New Jersey

  • Study site

    Chicago, Illinois

  • Study site

    Cincinnati, Ohio

  • Study site

    Cleveland, Ohio

  • Study site

    Columbia, South Carolina

  • Study site

    Dallas, Texas

  • Study site

    Denver, Colorado

  • Study site

    Fort Lauderdale, Florida

  • Study site

    Galveston, Texas

  • Study site

    Hampton, Virginia

  • Study site

    Hershey, Pennsylvania

  • Study site

    Houston, Texas

  • Study site

    Huntersville, North Carolina

  • Study site

    Long Beach, California

  • Study site

    Los Angeles, California

  • Study site

    Macon, Georgia

  • Study site

    Miami, Florida

  • Study site

    Miami Beach, Florida

  • Study site

    Milwaukee, Wisconsin

  • Study site

    New York, New York

  • Study site

    Oakland, California

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Phoenix, Arizona

  • Study site

    San Diego, California

  • Study site

    San Francisco, California

  • Study site

    Seattle, Washington

  • Study site

    Springfield, Massachusetts

  • Study site

    Tampa, Florida

  • Study site

    Vero Beach, Florida

  • Study site

    Washington D.C., District of Columbia

  • Study site

    West Hollywood, California

Other trials in United States

Argentina1 site

  • Study site

    Buenos Aires

Other trials in Argentina

About this study

Official title: A Phase II Randomized, Controlled, Partially Blinded Trial to Investigate Dose Response of TMC114/RTV in 3-class-experienced HIV-1 Infected Patients, Followed by an Open-label Period on the Recommended Dose of TMC114/RTV.

The purpose of this study is to determine the effectiveness, safety, and tolerability (how well the body stands the drug) of an investigational protease inhibitor (PI) called TMC114 given with low dose ritonavir.

Read the detailed description

A phase II randomized, controlled, partially blinded, trial to investigate dose response of TMC114/RTV in HIV-1 infected patients who have previously received all three licensed classes of HIV antiviral drugs (known as nucleoside reverse transcriptase inhibitors (NRTI), nonnucleoside reverse transcriptase inhibitors (NNRTI) and protease inhibitors (PI)), and who are on a stable PI-containing regimen not including an NNRTI may be eligible to participate. Four doses of TMC-114/ritonavir will be studied. 300 patients in the United States and Puerto Rico will participate. The duration of the study is 96 weeks. Randomize to one of 4 treatment groups (TMC114/RTV: 400/100 mg qd; 800/100mg qd; 400/100mg bid; 600/100 bid) or control arm for 24 to 48 wks. Optimal dose (TMC114/RTV 600/100mg bid) open label portion of the study. The trial was extended to include 144Wks of treatment.

Conditions
HIV Infections
Being tested
TMC114/rtv
Keywords
HIV, TMC114, Ritonavir, Tolerability, Safety and efficacy, TMC114-C211
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TMC114/rtvDrug

    800mg TMC114/100mg rtv once daily

  • TMC114/rtvDrug

    400mg TMC114/100mg rtv both twice daily

  • TMC114/rtvDrug

    400mg TMC114/100mg rtv once daily

  • TMC114/rtvDrug

    600mg TMC114/100mg rtv twice daily

Study groups in NCT00071097
Study groupRoleWhat they receive
001ExperimentalTMC114/rtv 400mg TMC114/100mg rtv once daily
Receives: Drug: TMC114/rtv
005No interventionControl Group Control Group, no intervention
004ExperimentalTMC114/rtv 600mg TMC114/100mg rtv twice daily
Receives: Drug: TMC114/rtv
003ExperimentalTMC114/rtv 400mg TMC114/100mg rtv both twice daily
Receives: Drug: TMC114/rtv
002ExperimentalTMC114/rtv 800mg TMC114/100mg rtv once daily
Receives: Drug: TMC114/rtv

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To evaluate the dose-response relationship of antiviral activity of the TMC114/RTV dose regimens at 24 Wks in order to determine the optimal dose.

    Measured: 24 weeks

Secondary outcomes (1)

  1. To evaluate safety and tolerability over 24 to 144Wks; The durability of the antiviral activity; The effect of functional monotherapy with TMC114 over 2 weeks in different doses; and The dose-response by comparing the different TMC114/RTV dosages.

    Measured: 144 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Oct 2003 (estimated)
  2. Study startOct 2003
  3. Primary completionFeb 2005
  4. Study completionNov 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
330 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00071097
Sponsor's protocol ID
CR006778
Other IDs
TMC114-C202
Status last verified
Sep 2016
First submitted
10 Oct 2003
Last updated
20 Sep 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Clotet B, Bellos N, Molina JM, Cooper D, Goffard JC, Lazzarin A, Wohrmann A, Katlama C, Wilkin T, Haubrich R, Cohen C, Farthing C, Jayaweera D, Markowitz M, Ruane P, Spinosa-Guzman S, Lefebvre E; POWER 1 and 2 study groups. Efficacy and safety of darunavir-ritonavir at week 48 in treatment-experienced patients with HIV-1 infection in POWER 1 and 2: a pooled subgroup analysis of data from two randomised trials. Lancet. 2007 Apr 7;369(9568):1169-78. doi: 10.1016/S0140-6736(07)60497-8.

    PubMed 17416261

  • De Meyer SM, Spinosa-Guzman S, Vangeneugden TJ, de Bethune MP, Miralles GD. Efficacy of once-daily darunavir/ritonavir 800/100 mg in HIV-infected, treatment-experienced patients with no baseline resistance-associated mutations to darunavir. J Acquir Immune Defic Syndr. 2008 Oct 1;49(2):179-82. doi: 10.1097/QAI.0b013e318183a959.

    PubMed 18769351

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TMC114/rtv in people with HIV Infections, run by Tibotec Pharmaceuticals, Ireland at 39 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 39 sites in United States, Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To evaluate the dose-response relationship of antiviral activity of the TMC114/RTV dose regimens at 24 Wks in order to determine the optimal dose. (time frame: 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00071097, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2016.

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