Human Immunodeficiency Virus-InfectionNCT01153269

Long-term Effectiveness and Safety in Hepatitis-co-infected Patients

An observational study of Human Immunodeficiency Virus-Infection, run by Abbott at 8 sites in Germany.

Completed

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

Trial summary

The aim of the study is to observe the tolerability and effectiveness of Kaletra in Human Immunodeficiency Virus/Hepatitis-B Virus and Human Immunodeficiency Virus/Hepatitis-C Virus co-infected patients. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Human Immunodeficiency Virus-Infection
What is being tested?: Lopinavir/Ritonavir (Kaletra)
Type of treatment: Pill or oral medicine
How many people: 33 participants
Where: 8 sitesGermany
Study dates: May 2001to Nov 2010
Phase: Observational
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

Study population: Community sample, Human Immunodeficiency Virus-infected patients with Hepatitis B or C co-infections

Who may be able to join

Patients infected by HIV-1 and HBV or HCV
Age ≥18 years
Patients who were initiated on a LPV/r containing antiretroviral (ARV) regimen

Who cannot join

Contraindications as described in SmPC (summary of product characteristics) at the time of prescription

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

Germany8 sites

Site Reference ID/Investigator# 27575
Berlin, 10243
Site Reference ID/Investigator# 27592
Berlin, 10961
Site Reference ID/Investigator# 27588
Dortmund, 44137
Site Reference ID/Investigator# 27583
Frankfurt, 60311
Site Reference ID/Investigator# 27587
Frankfurt, 60596
Site Reference ID/Investigator# 27607
Hamburg, 20099
Site Reference ID/Investigator# 5355
Krefeld, 47800
Site Reference ID/Investigator# 27604
Münster, 48149

Other trials in Germany

About this study

Conditions: Human Immunodeficiency Virus-Infection
Being tested: Lopinavir/Ritonavir (Kaletra)
Keywords: Human Immunodeficiency Virus, Co-infection with Hepatitis B or Hepatitis C, Tolerability, Effectiveness
Medical subject headings: Acquired Immunodeficiency Syndrome, Hepatitis C

What participants receive

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

Lopinavir/Ritonavir (Kaletra)Drug
3 capsules 2xdaily or 2 tablets 2xdaily Kaletra

Study groups in NCT01153269
Study group	Role	What they receive
HIV-infected patients with hepatitis co-infection		HIV-infected patients with co-infections of Hepatitis B or Hepatitis C Receives: Drug: Lopinavir/Ritonavir (Kaletra)

What is being measured

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

Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters
The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Baseline are presented.
Measured: Baseline
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters
The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 4 are presented.
Measured: Week 4
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters
The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 12 are presented.
Measured: Week 12
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters
The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 24 are presented.
Measured: Week 24
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters
The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 36 are presented.
Measured: Week 36
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters
The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 48 are presented.
Measured: Week 48
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters
The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 60 are presented.
Measured: Week 60
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters
The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 72 are presented.
Measured: Week 72
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters
The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 84 are presented.
Measured: Week 84
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters
The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 96 are presented.
Measured: Week 96
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters
The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 108 are presented.
Measured: Week 108
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters
The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 120 are presented.
Measured: Week 120
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters
The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 132 are presented.
Measured: Week 132
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters
The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 144 are presented.
Measured: Week 144
Viral Load
The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Baseline are presented.
Measured: Baseline
Viral Load
The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 4 are presented.
Measured: Week 4
Viral Load
The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 12 are presented.
Measured: Week 12
Viral Load
The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 24 are presented.
Measured: Week 24
Viral Load
The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 36 are presented.
Measured: Week 36
Viral Load
The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 48 are presented.
Measured: Week 48
Viral Load
The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 60 are presented.
Measured: Week 60
Viral Load
The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 72 are presented.
Measured: Week 72
Viral Load
The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 84 are presented.
Measured: Week 84
Viral Load
The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 96 are presented.
Measured: Week 96
Viral Load
The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 108 are presented.
Measured: Week 108
Viral Load
The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 120 are presented.
Measured: Week 120
Viral Load
The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 132 are presented.
Measured: Week 132
Viral Load
The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 144 are presented.
Measured: Week 144
CD4 Cell Count
The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Baseline are presented.
Measured: Baseline
CD4 Cell Count
The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 4 are presented.
Measured: Week 4
CD4 Cell Count
The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 12 are presented.
Measured: Week 12
CD4 Cell Count
The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 24 are presented.
Measured: Week 24
CD4 Cell Count
The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 36 are presented.
Measured: Week 36
CD4 Cell Count
The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 48 are presented.
Measured: Week 48
CD4 Cell Count
The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 60 are presented.
Measured: Week 60
CD4 Cell Count
The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 72 are presented.
Measured: Week 72
CD4 Cell Count
The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 84 are presented.
Measured: Week 84
CD4 Cell Count
The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 96 are presented.
Measured: Week 96
CD4 Cell Count
The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 108 are presented.
Measured: Week 108
CD4 Cell Count
The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 120 are presented.
Measured: Week 120
CD4 Cell Count
The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 132 are presented.
Measured: Week 132
CD4 Cell Count
The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 144 are presented.
Measured: Week 144

Timeline

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

May 2001Nov 2010

First posted30 Jun 2010 (estimated)
Study startMay 2001
Primary completionNov 2010
Study completionNov 2010

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.
Other trials for Human Immunodeficiency Virus-InfectionStudies of the same condition, open and under way.
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: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 33 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01153269
Sponsor's protocol ID: KAL 1 HO
Status last verified: Nov 2011
First submitted: 26 Feb 2010
Last updated: 19 Dec 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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?

See locations

Enrolling by invitation
Promoting Aging and Thriving With HIV
HIV (Human Immunodeficiency Virus), Geriatric
RecruitingObservational study
Cohort of Women Living With HIV-1 and Receiving Bictegravir/Emtricitabine/Tenofovir Alafenamide
HIV (Human Immunodeficiency Virus), Pregnancy
Enrolling by invitation
Effect of Omega-3 Supplementation on Pregnant Outcomes and Inflammation Markers of Women Infected With HIV Using Antiretroviral Therapy
Pregnant HIV Positive Women
Active, not recruitingPhase 2
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
Hepatitis B
RecruitingPhase 4
A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments
HIV-1-infection

All Human Immunodeficiency Virus-Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Long-term Effectiveness and Safety in Hepatitis-co-infected Patients
ClinicalTrials.gov ID: NCT01153269
Acronym / sponsor ID: KAL 1 HO
Conditions: Human Immunodeficiency Virus-Infection
Keywords: Human Immunodeficiency Virus, Co-infection with Hepatitis B or Hepatitis C, Tolerability, Effectiveness
Study type: Observational
Recruitment status: Completed
Enrolment: 33 participants (actual)
Lead sponsor: AbbottIndustry (pharma, biotech, devices)
Study start: May 2001
Primary completion: Nov 2010 (actual)
Study completion: Nov 2010 (actual)
First posted: 30 Jun 2010 (estimated)
Results: Posted 19 Dec 2011

Clinical summary

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

Study design

Observational model: Case only
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
HIV-infected patients with hepatitis co-infection	–	Drug: Lopinavir/Ritonavir (Kaletra)HIV-infected patients with co-infections of Hepatitis B or Hepatitis C

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Community sample, Human Immunodeficiency Virus-infected patients with Hepatitis B or C co-infections

Key inclusion criteria (3 listed)

Patients infected by HIV-1 and HBV or HCV
Age ≥18 years
Patients who were initiated on a LPV/r containing antiretroviral (ARV) regimen

Key exclusion criteria (1 listed)

Contraindications as described in SmPC (summary of product characteristics) at the time of prescription

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
Lopinavir/Ritonavir (Kaletra)3 capsules 2xdaily or 2 tablets 2xdaily Kaletra	Drug	HIV-infected patients with hepatitis co-infection

Primary outcome

Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters
Time frame: Baseline
The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Baseline are presented.
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters
Time frame: Week 4
The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 4 are presented.
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters
Time frame: Week 12
The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 12 are presented.
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters
Time frame: Week 24
The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 24 are presented.
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters
Time frame: Week 36
The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 36 are presented.
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters
Time frame: Week 48
The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 48 are presented.
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters
Time frame: Week 60
The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 60 are presented.
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters
Time frame: Week 72
The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 72 are presented.
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters
Time frame: Week 84
The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 84 are presented.
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters
Time frame: Week 96
The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 96 are presented.
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters
Time frame: Week 108
The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 108 are presented.
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters
Time frame: Week 120
The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 120 are presented.
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters
Time frame: Week 132
The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 132 are presented.
Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters
Time frame: Week 144
The decision to perform aspartate aminotransferase (AST) and alanine aminotransferase (ALT) laboratory tests to monitor participants' liver function was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 144 are presented.
Viral Load
Time frame: Baseline
The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Baseline are presented.
Viral Load
Time frame: Week 4
The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 4 are presented.
Viral Load
Time frame: Week 12
The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 12 are presented.
Viral Load
Time frame: Week 24
The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 24 are presented.
Viral Load
Time frame: Week 36
The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 36 are presented.
Viral Load
Time frame: Week 48
The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 48 are presented.
Viral Load
Time frame: Week 60
The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 60 are presented.
Viral Load
Time frame: Week 72
The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 72 are presented.
Viral Load
Time frame: Week 84
The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 84 are presented.
Viral Load
Time frame: Week 96
The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 96 are presented.
Viral Load
Time frame: Week 108
The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 108 are presented.
Viral Load
Time frame: Week 120
The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 120 are presented.
Viral Load
Time frame: Week 132
The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 132 are presented.
Viral Load
Time frame: Week 144
The decision to perform HIV-1 ribonucleic acid (RNA) tests to monitor participants' viral load was left to the treating physician's clinical judgment. The mean values and standard deviations for those tested at Week 144 are presented.
CD4 Cell Count
Time frame: Baseline
The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Baseline are presented.
CD4 Cell Count
Time frame: Week 4
The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 4 are presented.
CD4 Cell Count
Time frame: Week 12
The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 12 are presented.
CD4 Cell Count
Time frame: Week 24
The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 24 are presented.
CD4 Cell Count
Time frame: Week 36
The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 36 are presented.
CD4 Cell Count
Time frame: Week 48
The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 48 are presented.
CD4 Cell Count
Time frame: Week 60
The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 60 are presented.
CD4 Cell Count
Time frame: Week 72
The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 72 are presented.
CD4 Cell Count
Time frame: Week 84
The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 84 are presented.
CD4 Cell Count
Time frame: Week 96
The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 96 are presented.
CD4 Cell Count
Time frame: Week 108
The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 108 are presented.
CD4 Cell Count
Time frame: Week 120
The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 120 are presented.
CD4 Cell Count
Time frame: Week 132
The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 132 are presented.
CD4 Cell Count
Time frame: Week 144
The decision to perform laboratory tests to determine participants' CD4-positive (CD4+) T-lymphocyte counts was left to the treating physician's clinical judgment. The mean and standard deviation for those tested at Week 144 are presented.

Results and safety

Results posted to the registry on 19 Dec 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
HIV-infected Participants With Hepatitis Co-infection	33	31

Primary outcome: Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters

Time frame: Baseline. Mean (Standard Deviation). Unit: U/liter

Measure	HIV-infected Participants With Hepatitis Co-infection: AST n = 25	HIV-infected Participants With Hepatitis Co-infection: ALT n = 24
Value	64 (63)	69 (88)

Population analysed: Participants with aspartate aminotransferase and alanine aminotransferase results at Baseline.

Primary outcome: Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters

Time frame: Week 4. Mean (Standard Deviation). Unit: U/liter

Measure	HIV-infected Participants With Hepatitis Co-infection: AST n = 26	HIV-infected Participants With Hepatitis Co-infection: ALT n = 26
Value	85 (96)	85 (86)

Population analysed: Participants with aspartate aminotransferase and alanine aminotransferase results at Week 4.

Primary outcome: Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters

Time frame: Week 12. Mean (Standard Deviation). Unit: U/liter

Measure	HIV-infected Participants With Hepatitis Co-infection: AST n = 23	HIV-infected Participants With Hepatitis Co-infection: ALT n = 24
Value	69 (50)	85 (79)

Population analysed: Participants with aspartate aminotransferase and alanine aminotransferase results at Week 12.

Primary outcome: Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters

Time frame: Week 24. Mean (Standard Deviation). Unit: U/liter

Measure	HIV-infected Participants With Hepatitis Co-infection: AST n = 23	HIV-infected Participants With Hepatitis Co-infection: ALT n = 23
Value	78 (94)	97 (134)

Population analysed: Participants with aspartate aminotransferase and alanine aminotransferase results at Week 24.

Adverse events

Time frame: Investigators were instructed to report adverse events throughout the study (up to 3 years).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
HIV-infected Participants With Hepatitis Co-infection	0 of 33 (0%)	1 of 33 (3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Stefan Simianer, MD study director

Abbott Germany, Medical Department

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Human Immunodeficiency Virus-Infection, run by Abbott at 8 sites in Germany.

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 3 inclusion and 1 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 19 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Germany. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Dec 2011). 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?

Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) Parameters (time frame: Baseline). The study lists 42 primary outcomes in all. 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 NCT01153269.

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 19 Dec 2011.