HIV InfectionPhase 4HEATNCT00244712

Abacavir/Lamivudine Versus Emtricitabine/Tenofovir Both In Combination With Lopinavir/Ritonavir For The Treatment Of HIV

A Phase 4 study testing emtricitabine/tenofovir and abacavir/lamivudine in people with HIV Infection, run by GlaxoSmithKline at 74 sites in 2 countries.

Completed

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

Official record

Search all trials

Trial summary

This study was designed to test the safety and effectiveness of EPZICOM(abacavir/lamivudine) and TRUVADA (emtricitabine/tenofovir) for the treatment of HIV infection when both are used in combination with KALETRA (lopinavir/ritonavir) over 96 weeks Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: HIV Infection
What is being tested?: emtricitabine/tenofovir and abacavir/lamivudine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 688 participants
Where: 74 sitesin 2 countries
Study dates: Jul 2005to Apr 2008
Phase: Phase 4
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

Males as females at least 18 years old. (A female is eligible to enter and participate in this study if she is of: non child-bearing potential, child bearing potential with a negative pregnancy test and agrees to approved contraception methods, or agreement for complete abstinence.)
Subject is antiretroviral-naïve (defined as having ≤14 days of prior therapy with any NRTI and no prior therapy with either a PI or NNRTI).
Subject has plasma HIV-1 RNA ≥ 1,000 copies/mL at screening.
Subject is willing and able to understand and provide written informed consent prior to participation in this study.

Who cannot join

Subject has an active or acute CDC Clinical Category C event (exclusive of cutaneous Kaposi's sarcoma) at screening. Treatment for the acute event must have been completed at least 30 days prior to screening.
Subject is enrolled in one or more investigational drug protocols, which may impact HIV-1 RNA suppression.
Subject is, in the opinion of the investigator, unable to complete the 96-week dosing period and protocol evaluations and assessments.
Subject is either pregnant or breastfeeding.
Subject has an ongoing clinically relevant pancreatitis or clinically relevant hepatitis at screening.
Subject suffers from a serious medical condition, such as cirrhosis, diabetes, congestive heart failure, cardiomyopathy or other cardiac dysfunction, which in the opinion of the investigator would compromise the safety of the subject.

Show all 16Show fewer

Subject has a pre-existing mental, physical, or substance abuse disorder which, in the opinion of the investigator, may interfere with the subject's ability to comply with the dosing schedule and protocol evaluations and assessments.
Subject has a history of inflammatory bowel disease or malignancy, intestinal ischemia, malabsorption, or other gastrointestinal dysfunction which may interfere with drug absorption or render the subject unable to take oral medication.
Subject has any acute laboratory abnormality at screening, which, in the opinion of the investigator, precludes the subject's participation in the study of an investigational compound. Any grade 4 laboratory abnormality will exclude a subject from study participation.
Subject has estimated creatinine clearance <50 mL/min via Cockroft-Gault method.
Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >5 times the upper limit of normal (ULN).
Subject has required treatment with radiation therapy or cytotoxic chemotherapeutic agents within 28 days prior to screening, or has an anticipated need for these agents within the study period.
Subject requires treatment with immunomodulating agents (such as systemic corticosteroids, interleukins, vaccines, or interferons) within 28 days prior to Screen, or subject has received an HIV-1 immunotherapeutic vaccine within 90 days prior to Screen. Asthmatic subjects using inhaled corticosteroids are eligible for enrollment.
Subject requires treatment with foscarnet, hydroxyurea or other agents with documented activity against HIV-1 in vitro within 28 days of study administration.
Subjects who require treatment with the prohibited medications within 28 days of commencement of investigational product, or an anticipated need during the study.
Subject has a history of allergy to any of the study drugs or any excipients therein

Trial locations and contacts

74 sites in 2 countries.

Country

City, postcode or hospital

74 sites in 2 countries

United States72 sites

GSK Investigational Site
Annandale, Virginia, 22003
GSK Investigational Site
Atlanta, Georgia, 30308/30309
GSK Investigational Site
Atlanta, Georgia, 30308
GSK Investigational Site
Atlanta, Georgia, 30339
GSK Investigational Site
Augusta, Georgia, 30912
GSK Investigational Site
Austin, Texas, 78751
GSK Investigational Site
Baltimore, Maryland, 21201
GSK Investigational Site
Beverly Hills, California, 90210
GSK Investigational Site
Charlotte, North Carolina, 28209
GSK Investigational Site
Charlottesville, Virginia, 22908
GSK Investigational Site
Chicago, Illinois, 60612
GSK Investigational Site
Chicago, Illinois, 60637
GSK Investigational Site
Chicago, Illinois, 60657
GSK Investigational Site
Columbia, South Carolina, 29206
GSK Investigational Site
Dallas, Texas, 75208
GSK Investigational Site
Dallas, Texas, 75246
GSK Investigational Site
Decatur, Georgia, 30033
GSK Investigational Site
Denver, Colorado, 80204
GSK Investigational Site
Denver, Colorado, 80205
GSK Investigational Site
Denver, Colorado, 80220
GSK Investigational Site
Fort Lauderdale, Florida, 33306
GSK Investigational Site
Fort Lauderdale, Florida, 33308
GSK Investigational Site
Fort Lauderdale, Florida, 33316
GSK Investigational Site
Fort Myers, Florida, 33901
GSK Investigational Site
Fort Worth, Texas, 76104
GSK Investigational Site
Fountain Valley, California, 92708
GSK Investigational Site
Garden Grove, California, 92845
GSK Investigational Site
Glastonbury, Connecticut, 06033
GSK Investigational Site
Greenville, North Carolina, 27834
GSK Investigational Site
Hampton, Virginia, 23666
GSK Investigational Site
Harlingen, Texas, 78550
GSK Investigational Site
Hillsborough, New Jersey, 08844
GSK Investigational Site
Houston, Texas, 77027
GSK Investigational Site
Houston, Texas, 77030
GSK Investigational Site
Key West, Florida, 33040
GSK Investigational Site
Las Vegas, Nevada, 89102
GSK Investigational Site
Lexington, Kentucky, 40536
GSK Investigational Site
Long Beach, California, 90813
GSK Investigational Site
Longview, Texas, 75604
GSK Investigational Site
Los Angeles, California, 90069
GSK Investigational Site
Louisville, Kentucky, 40202
GSK Investigational Site
Lynchburg, Virginia, 24501
GSK Investigational Site
Maywood, Illinois, 60153
GSK Investigational Site
Miami, Florida, 33136
GSK Investigational Site
Milwaukee, Wisconsin, 53226
GSK Investigational Site
New York, New York, 10011
GSK Investigational Site
New York, New York, 10065
GSK Investigational Site
Newark, New Jersey, 07102
GSK Investigational Site
Newport Beach, California, 92663
GSK Investigational Site
Norwalk, Connecticut, 06851
GSK Investigational Site
Oakland, California, 94602
GSK Investigational Site
Oakland, California, 94609
GSK Investigational Site
Philadelphia, Pennsylvania, 19140
GSK Investigational Site
Phoenix, Arizona, 85006
GSK Investigational Site
Phoenix, Arizona, 85012
GSK Investigational Site
Plantation, Florida, 33317
GSK Investigational Site
Port Saint Lucie, Florida, 34952
GSK Investigational Site
Portland, Oregon, 97219
GSK Investigational Site
Rochester, New York, 14604
GSK Investigational Site
Sarasota, Florida, 34239
GSK Investigational Site
Sarasota, Florida, 34243
GSK Investigational Site
Somers Point, New Jersey, 08244
GSK Investigational Site
St Louis, Missouri, 63108
GSK Investigational Site
Tampa, Florida, 33602
GSK Investigational Site
Tampa, Florida, 33614
GSK Investigational Site
Toledo, Ohio, 43614
GSK Investigational Site
Tucson, Arizona, 85745
GSK Investigational Site
Tyler, Texas, 75708
GSK Investigational Site
Washington D.C., District of Columbia, 20007
GSK Investigational Site
Washington D.C., District of Columbia, 20009
GSK Investigational Site
Washington D.C., District of Columbia, 20037
GSK Investigational Site
West Reading, Pennsylvania, 19611

Other trials in United States

Puerto Rico2 sites

GSK Investigational Site
Ponce, 00731
GSK Investigational Site
San Juan, 00909-1711

Other trials in Puerto Rico

About this study

Official title: A 96-Week, Phase IV, Randomized, Double-Blind, Multicenter Study of the Safety and Efficacy of EPZICOM Versus TRUVADA Administered in Combination With KALETRA in Antiretroviral-Naive HIV-1 Infected Subjects

Conditions: HIV Infection
Being tested: emtricitabine/tenofovir, abacavir/lamivudine
Keywords: HEAT, Antiretroviral-naive, HIV, EPZICOM, TRUVADA, KALETRA, once-daily
Medical subject headings: HIV Infections

What participants receive

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

emtricitabine/tenofovirDrug
The intervention is an active comparator regimen containing tenofovir/emtricitabine + abacavir/lamivudine placebo + lopinavir/ritonavir.
abacavir/lamivudineDrug
The experimental intervention is a regimen containing abacavir/lamivudine + tenofovir/emtricitabine placebo + lopinavir/ritonavir.

Study groups in NCT00244712
Study group	Role	What they receive
ABC/3TC	Experimental	The intervention is a regimen containing abacavir/lamivudine + tenofovir/emtricitabine placebo +lopinavir/ritonavir. Receives: Drug: abacavir/lamivudine
TDF/FTC	Active comparator	The intervention is a regimen containing tenofovir/emtricitabine + abacavir/lamivudine placebo + lopinavir/ritonavir. Receives: Drug: emtricitabine/tenofovir

What is being measured

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

Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48 by Missing=Failure (M=F), Switched Included Analysis.
A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Week 48. The percentage of participants with HIV-1 RNA <50 copies/mL were tabulated by treatment arm with stratification by baseline HIV-1 RNA (<100,000 copies/mL and >=100,000 copies/mL).
Measured: Week 48

Secondary outcomes (13)

Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48
A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Week 48. The percentage of participants with HIV-1 RNA <50 copies/mL at Week 48 were tabulated by treatment arm with stratification by baseline HIV-1 RNA levels (<100,000 copies/mL and >=100,000 copies/mL).
Measured: Week 48
Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 96
A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Week 96. The percentage of participants with HIV-1 RNA <50 copies/mL at Week 96 were tabulated by treatment arm with stratification by baseline HIV-1 RNA levels (<100,000 copies/mL and >=100,000 copies/mL).
Measured: Week 96
Percentage of Participants With HIV-1 RNA <50 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA <100,000 Copies/mL
A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Weeks 48 and 96. The percentage of participants with HIV-1 RNA <50 copies/mL at Weeks 48 and 96 were tabulated by treatment arm in participants with baseline HIV-1 RNA <100,000 copies/mL.
Measured: Weeks 48 and 96
Percentage of Participants With HIV-1 RNA <50 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA >=100,000 Copies/mL
A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Week 48 and 96. The percentage of participants with HIV-1 RNA <50 copies/mL at Weeks 48 and 96 were tabulated by treatment arm in participants with baseline HIV-1 RNA >=100,000 copies/mL.
Measured: Weeks 48 and 96
Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96
A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Week 48 and 96. The percentage of participants with HIV-1 RNA <400 copies/mL at Weeks 48 and 96 were tabulated by treatment arm with stratification by baseline HIV-1 RNA levels (<100,000 copies/mL and >=100,000 copies/mL).
Measured: Weeks 48 and 96
Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA <100,000 Copies/mL
A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Weeks 48 and 96. The percentage of participants with HIV-1 RNA <400 copies/mL at Weeks 48 and 96 were tabulated by treatment arm in participants with baseline HIV-1 RNA <100,000 copies/mL.
Measured: Weeks 48 and 96
Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA >=100,000 Copies/mL
A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Weeks 48 and 96. The percentage of participants with HIV-1 RNA <400 copies/mL at Weeks 48 and 96 were tabulated by treatment arm in participants with baseline HIV-1 RNA >=100,000 copies/mL.
Measured: Weeks 48 and 96
Median Change From Baseline in HIV-1 RNA at Week 48 and 96
A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Weeks 48 and 96. Change from baseline was defined as HIV-1 RNA level at Weeks 48 and 96 minus HIV-1 RNA level at baseline.
Measured: Weeks 48 and 96
Median Change From Baseline in CD4+ Cells at Weeks 48 and 96
A blood sample was drawn to determine the CD4+ cell count at Weeks 48 and 96. Change from baseline was defined as CD4+ cell count at week 96 minus CD4+ cell count at baseline.
Measured: Weeks 48 and 96
Number of Participants Who Meet the Protocol-defined Virologic Failure (PDVF) Criteria at Week 96
The number of participants that failed to respond to therapy based on the protocol definition of virologic failure (PDVF) was tabulated. PDVF was defined as either no confirmed HIV-1 RNA <200 copies/mL or HIV-1 RNA rebound >= 200 copies/mL on two consecutive occasions.
Measured: Baseline to Week 96
Number of Confirmed Virologic Failure Participants Who Had Treatment-emergent Genotypic Resistance Through 96 Weeks
A blood sample was drawn for participants failing to respond to therapy and the mutations present in the virus were identified. For each participant, the mutations found at the time of failure were compared with any mutations found in the blood sample at baseline. New mutations that developed at the time of failure was tabulated by drug class. NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; PI, protease inhibitor.
Measured: Baseline and time of virologic failure (up to Week 96)
Number of Confirmed Virologic Failure Participants at Week 96 With Genotypic Resistance to Lamivudine (3TC) and Emtricitabine (FTC) and Had Phenotypic Reduced Susceptibility
A blood sample was drawn for participants failing to respond to therapy and the mutations present in the virus were identified. New mutations that developed to the NRTI class at the time of failure that no longer responded to lamivudine or emtricitabine were tabulated by drug class.
Measured: Baseline and time of virologic failure (up to Week 96)
Number of Participants Who Reported a Suspected Abacavir Hypersensitivity Reaction (ABC HSR) Reaction or Proximal Renal Tubule Dysfunction
The number of participants that experienced symptoms of a suspected abacavir hypersensitivity reaction was tabulated. The number of participants that developed laboratory signs of proximal renal tubule dysfunction was tabulated.
Measured: Baseline through 96 weeks

Timeline

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

Jul 2005Apr 2008

First posted27 Oct 2005 (estimated)
Study startJul 2005
Primary completionApr 2008
Study completionApr 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HIV InfectionStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 688 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00244712
Sponsor's protocol ID: EPZ104057
Other IDs: EPZ104057
Acronym: HEAT
Status last verified: Jun 2010
First submitted: 25 Oct 2005
Last updated: 8 Jun 2010
Results posted: Yes, on ClinicalTrials.gov

Publications

Smith KY, Patel P, Fine D, Bellos N, Sloan L, Lackey P, Kumar PN, Sutherland-Phillips DH, Vavro C, Yau L, Wannamaker P, Shaefer MS; HEAT Study Team. Randomized, double-blind, placebo-matched, multicenter trial of abacavir/lamivudine or tenofovir/emtricitabine with lopinavir/ritonavir for initial HIV treatment. AIDS. 2009 Jul 31;23(12):1547-56. doi: 10.1097/QAD.0b013e32832cbcc2.
PubMed 19542866

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All HIV Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 96-Week, Phase IV, Randomized, Double-Blind, Multicenter Study of the Safety and Efficacy of EPZICOM Versus TRUVADA Administered in Combination With KALETRA in Antiretroviral-Naive HIV-1 Infected Subjects
ClinicalTrials.gov ID: NCT00244712
Acronym / sponsor ID: HEAT / EPZ104057
Conditions: HIV Infection
Keywords: HEAT, Antiretroviral-naive, HIV, EPZICOM, TRUVADA, KALETRA, once-daily
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 688 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: Jul 2005
Primary completion: Apr 2008 (actual)
Study completion: Apr 2008 (actual)
First posted: 27 Oct 2005 (estimated)
Results: Posted 15 Sep 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
ABC/3TC	Experimental	Drug: abacavir/lamivudineThe intervention is a regimen containing abacavir/lamivudine + tenofovir/emtricitabine placebo +lopinavir/ritonavir.
TDF/FTC	Active comparator	Drug: emtricitabine/tenofovirThe intervention is a regimen containing tenofovir/emtricitabine + abacavir/lamivudine placebo + lopinavir/ritonavir.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Males as females at least 18 years old. (A female is eligible to enter and participate in this study if she is of: non child-bearing potential, child bearing potential with a negative pregnancy test and agrees to approved contraception methods, or agreement for complete abstinence.)
Subject is antiretroviral-naïve (defined as having ≤14 days of prior therapy with any NRTI and no prior therapy with either a PI or NNRTI).
Subject has plasma HIV-1 RNA ≥ 1,000 copies/mL at screening.
Subject is willing and able to understand and provide written informed consent prior to participation in this study.

Key exclusion criteria (16 listed)

Subject has an active or acute CDC Clinical Category C event (exclusive of cutaneous Kaposi's sarcoma) at screening. Treatment for the acute event must have been completed at least 30 days prior to screening.
Subject is enrolled in one or more investigational drug protocols, which may impact HIV-1 RNA suppression.
Subject is, in the opinion of the investigator, unable to complete the 96-week dosing period and protocol evaluations and assessments.
Subject is either pregnant or breastfeeding.
Subject has an ongoing clinically relevant pancreatitis or clinically relevant hepatitis at screening.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
emtricitabine/tenofovirThe intervention is an active comparator regimen containing tenofovir/emtricitabine + abacavir/lamivudine placebo + lopinavir/ritonavir.	Drug	TDF/FTC
abacavir/lamivudineThe experimental intervention is a regimen containing abacavir/lamivudine + tenofovir/emtricitabine placebo + lopinavir/ritonavir.	Drug	ABC/3TC

Primary outcome

Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48 by Missing=Failure (M=F), Switched Included Analysis.
Time frame: Week 48
A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Week 48. The percentage of participants with HIV-1 RNA <50 copies/mL were tabulated by treatment arm with stratification by baseline HIV-1 RNA (<100,000 copies/mL and >=100,000 copies/mL).

13 secondary outcomes

Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48
Time frame: Week 48
Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 96
Time frame: Week 96
Percentage of Participants With HIV-1 RNA <50 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA <100,000 Copies/mL
Time frame: Weeks 48 and 96
Percentage of Participants With HIV-1 RNA <50 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA >=100,000 Copies/mL
Time frame: Weeks 48 and 96
Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96
Time frame: Weeks 48 and 96
Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA <100,000 Copies/mL
Time frame: Weeks 48 and 96
Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA >=100,000 Copies/mL
Time frame: Weeks 48 and 96
Median Change From Baseline in HIV-1 RNA at Week 48 and 96
Time frame: Weeks 48 and 96
Median Change From Baseline in CD4+ Cells at Weeks 48 and 96
Time frame: Weeks 48 and 96
Number of Participants Who Meet the Protocol-defined Virologic Failure (PDVF) Criteria at Week 96
Time frame: Baseline to Week 96
Number of Confirmed Virologic Failure Participants Who Had Treatment-emergent Genotypic Resistance Through 96 Weeks
Time frame: Baseline and time of virologic failure (up to Week 96)
Number of Confirmed Virologic Failure Participants at Week 96 With Genotypic Resistance to Lamivudine (3TC) and Emtricitabine (FTC) and Had Phenotypic Reduced Susceptibility
Time frame: Baseline and time of virologic failure (up to Week 96)
Number of Participants Who Reported a Suspected Abacavir Hypersensitivity Reaction (ABC HSR) Reaction or Proximal Renal Tubule Dysfunction
Time frame: Baseline through 96 weeks

Results and safety

Results posted to the registry on 15 Sep 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)	343	234
Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV	345	221

Primary outcome: Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48 by Missing=Failure (M=F), Switched Included Analysis.

Time frame: Week 48. Number. Unit: percentage of participants

Measure	Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) n = 343	Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV n = 345
Value	67.5	67.2

Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV) vs Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV: difference in response percentage: 0.39 (95% CI -6.63 to 7.40), p = 0.913, Cochran-Mantel-Haenszel

Population analysed: The Intent-To-Treat-Exposed (ITT-E) population which included all randomized participants that had received at least one dose of study medication. In the missing=failure, switched included analysis, participants who had switched their randomized treatment for other treatment were considered as failures, i.e., HIV-1 RNA \>=50 copies/mL.

13 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)	42 of ?	182 of ?	Not reported
Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV	45 of ?	182 of ?	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2010.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 19542866Smith KY, Patel P, Fine D, Bellos N, Sloan L, Lackey P, Kumar PN, Sutherland-Phillips DH, Vavro C, Yau L, Wannamaker P, Shaefer MS; HEAT Study Team. Randomized, double-blind, placebo-matched, multicenter trial of abacavir/lamivudine or tenofovir/emtricitabine with lopinavir/ritonavir for initial HIV treatment. AIDS. 2009 Jul 31;23(12):1547-56. doi: 10.1097/QAD.0b013e32832cbcc2.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

74 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing emtricitabine/tenofovir and abacavir/lamivudine in people with HIV Infection, run by GlaxoSmithKline at 74 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 4 inclusion and 16 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 8 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 74 sites in United States, Puerto Rico. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 15 Sep 2009). 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?

Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48 by Missing=Failure (M=F), Switched Included Analysis. (time frame: Week 48). 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 NCT00244712, 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 8 Jun 2010.