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HIVPhase 2SPARTANNCT00768989

Phase IIB Pilot of Atazanavir + Raltegravir

A Phase 2 study testing Atazanavir, Raltegravir and Ritonavir in people with HIV, run by Bristol-Myers Squibb at 16 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to determine if the combination of atazanavir and raltegravir taken together is safe and effective in the treatment of human immunodeficiency virus (HIV). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV
What is being tested?
Atazanavir, Raltegravir and Ritonavir
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
167 participants
Where
16 sitesin 3 countries
Study dates
Nov 2008to May 2010
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Human Immunodeficiency Virus (HIV)-1 positive status
  • HIV ribonucleic acid (RNA) level >=5000 copies/mL
  • Antiretroviral treatment-naive
  • Absolute Cluster of Differentiation 4 (CD4) cell count meeting 1 of the following criteria:
  • <350 cells/mm^3
  • Screening CD4 >=350 and <=500 cells/mm^3 ONLY if at least 1 of the following conditions apply:
Show all 11Show fewer
  • Screening HIV RNA level >100,000 copies/mL, or
  • CD4 decline >50-100 cells/mm^3/year, or
  • Age >=55 years
  • Any CD4 cell count, if participant has a history of an acquired immune deficiency syndrome-defining illness
  • Medically stable

Who cannot join

  • Screening HIV genotype showing resistance to any component of the study regimen (Atazanavir, Raltegravir, Tenofovir/Emtricitabine)
  • Hepatitis B or hepatitis C coinfection
  • History of or current cardiac disease
  • Electrocardiogram findings:
  • PR Interval >260 msec (severe 1st degree atrioventricular block)
  • QRS Interval >120 msec

Trial locations and contacts

16 sites in 3 countries.

16 sites in 3 countries

United States9 sites

  • University Of Cincinnati

    Cincinnati, Ohio, 45267

  • Tarrant County Infectious Disease Associates

    Fort Worth, Texas, 76104

  • Therapeutic Concepts, P.A.

    Houston, Texas, 77004

  • Diversified Medical Practices, P.A.

    Houston, Texas, 77057

  • Yale University School Of Medicine

    New Haven, Connecticut, 06510

  • The Aaron Diamond AIDS Research Center

    New York, New York, 10016

  • Orlando Immunology Center

    Orlando, Florida, 32803

  • Southwest Center For HIV/AIDS

    Phoenix, Arizona, 85006

  • Dupont Circle Physicians Group

    Washington D.C., District of Columbia, 20009

Other trials in United States

Argentina4 sites

  • Local Institution

    Buenos Aires, Bs As, Buenos Aires, 1141

  • Local Institution

    Capital Federal, Buenos Aires, 1264

  • Local Institution

    Mar del Plata, Buenos Aires, B7600CTO

  • Local Institution

    Rosario, Santa Fe Province, 2000

Other trials in Argentina

France3 sites

  • Local Institution

    Nantes, 44035

  • Local Institution

    Paris, 75475

  • Local Institution

    Paris, 75970

Other trials in France

About this study

Official title: A Multicenter, Randomized, Open-Label, Active-Controlled Pilot Study to Evaluate the Safety and Antiretroviral Activity of Unboosted Atazanavir BID Plus Raltegravir BID and Boosted Atazanavir QD in Combination With Tenofovir/Emtricitabine QD in Treatment Naive HIV-Infected Subjects

The purpose of this study is to determine if the combination of atazanavir and raltegravir taken together is safe and effective in the treatment of human immunodeficiency virus (HIV).

Conditions
HIV
Being tested
Atazanavir, Raltegravir, Ritonavir, Tenofovir/Emtricitabine
Keywords
Combination Therapy

What participants receive

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

  • AtazanavirDrug

    Also called Reyataz, BMS-232632

    Capsules, Oral, 300 mg, twice daily, 96 weeks

  • RaltegravirDrug

    Tablet, Oral, 400 mg, twice daily, 96 weeks

  • AtazanavirDrug

    Also called Reyataz, BMS-232632

    Capsules, Oral, 300 mg, once daily, 96 weeks

  • RitonavirDrug

    Capsules, Oral, 100 mg, once daily, 96 weeks

  • Tenofovir/EmtricitabineDrug

    Also called Truvada

    Tablet, Oral, 300-mg Tenofovir/200-mg Emtricitabine, once daily, 96 weeks

Study groups in NCT00768989
Study groupRoleWhat they receive
Atazanavir + RaltegravirExperimentalAtazanavir 300 mg twice daily + Raltegravir 400 mg twice daily
Receives: Drug: Atazanavir; Drug: Raltegravir
Atazanavir + Ritonavir + Tenofovir /EmtricitabineActive comparatorAtazanavir, 300 mg once daily, + Ritonavir, 100 mg once daily, + Tenofovir 300 mg/Emtricitabine, 200 mg once daily
Receives: Drug: Atazanavir; Drug: Ritonavir; Drug: Tenofovir/Emtricitabine

What is being measured

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

  1. Number of Participants With Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) Level <50 Copies/mL at Week 24

    The number of HIV 1-infected treatment-naive participants with an HIV RNA level <50 copies/mL after 24 weeks of treatment. Confirmed virologic response noncompleter=failure (NC=F); noncompleter=missing (NC=M); virologic response-observed cases (VR-OC).

    Measured: At Week 24 from Baseline

Secondary outcomes (28)

  1. Number of Nonresponders at Week 8

    Participants were classified as nonresponders if they had an HIV RNA level ≥400 copies/mL and a decrease from baseline <2 log10 copies/mL.

    Measured: At Week 8 from Baseline

  2. Number of Participants With HIV RNA Levels <50 Copies/mL at Weeks 48 and 96

    Participant HIV RNA level was determined at Weeks 48 and 96 using the Roche Amplicor® Ultrasensitive Assay Version 1. VR-OC=Virologic response-observed cases.

    Measured: At Weeks 48 and 96 from Baseline

  3. Number of Participants With HIV RNA Levels <400 Copies/mL at Week 24

    NC=F: noncompleter=failure; NC=M: noncompleter=missing; VR-OC: virologic response-observed

    Measured: At Week 24 from Baseline

  4. Number of Participants With HIV RNA Levels <400 Copies/mL at Week 48

    Measured: At Week 48 from Baseline

  5. Number of Participants With HIV RNA Levels <400 Copies/mL at Week 96

    Measured: At Week 96 from Baseline

  6. Mean Change From Baseline in Absolute Cluster of Differentiation 4 Cell Count

    Measured: From Baseline to Weeks 2, 4, 8, 12, 16, 20, and 24

  7. Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Death as Outcome, AEs Leading to Discontinuation, SAEs Leading to Discontinuation

    AE=any new untoward medical occurrence or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in drug dependency or drug abuse, or is an important medical event.

    Measured: Week 1 to Week 96, continuously

  8. Baseline and Mean Change From Baseline in Total Cholesterol Levels

    The mean change from baseline in participant fasting lipids was determined using fasting serum samples.

    Measured: From Baseline to Week 24 and Week 48

  9. Mean Change From Baseline in Total Bilirubin Level

    Measured: From Baseline to Week 24 and Week 48

  10. Mean Change From Baseline in Electrocardiogram Findings

    The incidence of QRS wave widening and QT and PR prolongation on participant electrocardiogram findings were evaluated at study Week 24.

    Measured: From Baseline to Week 24

  11. Atazanavir Maximum Observed Plasma Concentration (Cmax) in 1 Dosing Interval

    Serial blood samples were collected over a 12-hour period after the morning dose at Week 2.

    Measured: At Week 2 from Baseline

  12. Raltegravir Cmax in 1 Dosing Interval

    Serial blood samples were collected over a 12-hour period after the morning dose at Week 2.

    Measured: At Week 2 from Baseline

  13. Atazanavir Time of Maximum Observed Plasma Concentration (Tmax)

    Serial blood samples were collected over a 12-hour period after the morning dose at Week 2.

    Measured: At Week 2 from Baseline

  14. Raltegravir Tmax

    Serial blood samples were collected over a 12-hour period after the morning dose at Week 2.

    Measured: At Week 2 from Baseline

  15. Atazanavir Trough Plasma Concentration (Cmin) 12 Hours Postdose

    Measured: At Week 2 from Baseline

  16. Raltegravir Cmin 12 Hours Postdose

    Measured: At Week 2 from Baseline

  17. Atazanavir Cmin Prior to the Morning Dose

    Measured: At Week 2 from Baseline

  18. Raltegravir Cmin Prior to the Morning Dose

    Measured: At Week 2 from Baseline

  19. Atazanavir Area Under the Concentration Curve From Time 0 to 12 Hours (AUC [0-12h]) in 1 Dosing Interval

    Measured: At Week 2 from Baseline

  20. Raltegravir AUC (0-12h) in 1 Dosing Interval

    Measured: At Week 2 from Baseline

  21. Atazanavir Area Under the Concentration Curve From Time 0 to 24 Hours (AUC [0-24h]) in 1 Dosing Interval

    AUC (0-24h) was estimated by multiplying AUC (0-12h) by 2.

    Measured: At Week 2 from Baseline

  22. Atazanavir Individual Inhibitory Quotient (IQ)

    Individual IQ was defined at Cmin at Week 2 divided by the protein binding adjusted EC90 (ie, the drug concentration observed to inhibit virion production by 90% in a cell-based assay) values for Atazanavir that were derived from individual participant clinical isolates.

    Measured: At Week 2 from Baseline

  23. Atazanavir Terminal Elimination Half Life

    Measured: At Week 2 from Baseline

  24. Raltegravir Terminal Elimination Half Life

    Measured: At Week 2 from Baseline

  25. Number of Participants With Hematology Laboratory Test Results With Worst Toxicity of Grades 1 to 4 Among All Treated Participants

    ULN=upper limit of normal. Hematocrit(%) Grade (Gr) 1: ≥28.5-<31; Gr 2: ≥24-<28.5; Gr 3: ≥19.5-<24; Gr 4: <19.5. Hemoglobin (g/dL) Gr 1: 9.5-11; Gr 2: 8-9.4; Gr 3: 6.5-7.9; Gr 4: <6.5. Platelets (/mm^3) Gr 1: 75,000-99,000; Gr 2: 50,000-74,999; Gr 3: 20,000-49,999; Gr 4: <20,000. White Blood Cells (/mm^3) Gr 1: >2500-4000; Gr 2: >1000-<2500; Gr 3: >800-<1000; Gr 4: <800. . Prothrombin time (seconds) Gr 1: 1.01-1.25*ULN; Gr 2: 1.26-1.5*ULN; Gr 3: 1.51-3*ULN; Gr 4: >3*ULN.

    Measured: While on treatment from Baseline through Week 96

  26. Number of Participants With Blood Chemistry Laboratory Test Results With Worst Toxicity of Grades 1 to 4

    Blood urea nitrogen Gr 1:1.25-2.5*ULN;Gr 2:2.6-5.0*ULN; Gr 3:5.1-10*ULN; Gr 4:>10*ULN. Creatinine (mg/dL) Gr 1: 1.1-1.5 *ULN; Gr 2: 1.6-3*ULN: Gr 3: 3.1-6*ULN; Gr 4: >6*ULN. Hypercarbia (meq/L)Gr 1: 33-36; Gr 2:37-40; Gr 3: 41-45; Gr 4:>45. Hypocarbia (meq/L)Gr 1:19-21; Gr 2: 15-18; Gr 3: 10-14; Gr 4:<10. Hypercalcemia (mg/dL)Gr 1:10.6-11.5;Gr 2:11.6-12.5; Gr 3:12.6-13.5;Gr 4: >13.5. Hypocalcemia (mg/dL)Gr 1: 8.4-7.8;Gr 2:7.7-7; Gr 3:6.9-6.1; Gr 4: <6.1.Hyperchloremia(meq/L)Gr 1:113-116; Gr 2:117-120; Gr 3:121-125; Gr 4: >125.Hypochloremia(meq/L)Gr 1: 90-93; Gr 2: 85-89; Gr 3:80-84; Gr 4:<80.

    Measured: While on treatment from Baseline through Week 96

  27. Number of Participants With Blood Chemistry Laboratory Test Results With Worst Toxicity of Grades 1 to 4 (Continued)

    Hyperkalemia(meq/L) Gr 1: 5.6-6; Gr 2: 6.1-6.5; Gr 3: 6.6-7; Gr4: >7. Hypokalemia(meq/L) Gr 1: 3-3.4; Gr 2: 2.5-2.9; Gr 3: 2-2.4; Gr 4:<2. Hypernatremia (meq/L) Gr 1: 148-150; Gr 2: 151-157; Gr 3: 148-165; Gr 4: >165. Hyponatremia (meq/L) Gr 1: 130-132; Gr 2: 123-129; Gr 3: 116-122; Gr 4: >115.Hyperglycemia(mg/dL)Gr 1: 116-160; Gr 2: 161-250; Gr 3: 251-500; Gr 4: >500. Hypoglycemia(mg/dL)Gr 1: 55-64; Gr 2: 40-54; Gr 3:30-39;Gr 4:<30.Creatine kinase (IU/L) Gr 1: >ULN-1.5*ULN; Gr 2: 1.5-3*ULN; Gr 3: >3-6*ULN; Gr 4: >6.0*ULN. Albumin (g/dL) Gr 1: <LLN-30; Gr 2: <30-20; Gr 3\&4: <20.

    Measured: While on treatment from Baseline through Week 96

  28. Number of Participants With Enzyme and Urine Laboratory Test Results With Worst Toxicity of Grades 1 to 4

    AST/SGOT=Aspartate aminotransferase/serum glutamate oxaloacetate transaminase; ALT/SGPT=Alanine transaminase/serum glutamic pyruvic transaminase. Bilirubin (mg/dL)Gr 1: 1.1-1.5*ULN;Gr 2:1.6-2.5*ULN;Gr3:2.6-5*ULN;Gr4:>5*ULN.AST/SGOT(U/L)Gr 1:1.25-2.5*ULN;Gr 2: 2.6-5*ULN;Gr 3:5.1-10*ULN;Gr4:>10*ULN.ALT/SGPT (U/L)Gr 1:1.25-2.5*ULN;Gr 2:1.4-2.09*ULN;Gr 3:5.1-10*ULN;Gr4:>10*ULN. Lipase(U/L)Gr 1:1.1-1.39*ULN;Gr 2:>1.5-2*ULN;Gr 3:2.5-5;Gr 4:5*ULN.Proteinuria(g/24 hr loss)Gr 1:1+or <1;Gr 2:2-3+or>1-2; Gr 3:4+or>2-3.5;Gr4:>3.5.Creatine kinase(IU/L)Gr1:2-3*ULN;Gr 2:3.1-5*ULN;Gr 3:5.1-10*ULN;Gr4:>10*ULN.

    Measured: While on treatment from Baseline through Week 96

Timeline

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

  1. First posted8 Oct 2008 (estimated)
  2. Study startNov 2008
  3. Primary completionJan 2010
  4. Study completionMay 2010

Why it stopped: Efficacy endpoint met, but overall experimental dosing regimen not considered optimal to support further clinical development in this population.

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
None (open label)
Enrolment
167 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00768989
Sponsor's protocol ID
AI424-376
Acronym
SPARTAN
Status last verified
Feb 2012
First submitted
6 Oct 2008
Last updated
24 Feb 2012
Data monitoring committee
No

Publications

  • Kozal MJ, Lupo S, DeJesus E, Molina JM, McDonald C, Raffi F, Benetucci J, Mancini M, Yang R, Wirtz V, Percival L, Zhang J, Zhu L, Arikan D, Farajallah A, Nguyen BY, Leavitt R, McGrath D, Lataillade M, The Spartan Study Team. A nucleoside- and ritonavir-sparing regimen containing atazanavir plus raltegravir in antiretroviral treatment-naive HIV-infected patients: SPARTAN study results. HIV Clin Trials. 2012 May-Jun;13(3):119-30. doi: 10.1310/hct1303-119.

    PubMed 22592092

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Atazanavir, Raltegravir and Ritonavir in people with HIV, run by Bristol-Myers Squibb at 16 sites in 3 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 11 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: stopped early, as of the sponsor's last update on 24 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United States, Argentina, France. 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?

Yes. Results are posted in the registry (first posted 16 Jan 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) Level <50 Copies/mL at Week 24 (time frame: At Week 24 from Baseline). 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 NCT00768989, which also lists 1 linked publication.

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 24 Feb 2012.

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