HIV InfectionsPhase 4NCT00885664
Immune Reconstitution as a Determinant of Adverse Effects to New Antiretroviral Therapy in Persons With Advanced HIV Infection
A Phase 4 study testing Truvada (tenofovir/emtricitabine) and Kaletra (lopinavir/ritonavir) in people with HIV Infections, run by University of Cincinnati at 1 site in United States.
Trial summary
The purposes of this study are: 1. To understand whether the use of HIV therapy in persons with more advanced HIV disease results in greater side effects. 2. To determine whether these side effects can be related to greater activation of the immune system. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Truvada (tenofovir/emtricitabine) and Kaletra (lopinavir/ritonavir)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2005to Mar 2010
- 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
- Age > 18 years
- Diagnosis of HIV infection.
- Naive to antiretroviral therapy OR no use of antiretrovirals for ≥ 6 months.
Who cannot join
- Blinded drug treatment.
- Active untreated serious infection within 14 days of enrollment that in the opinion of the investigator would affect the subject's participation and/or safety in the study.
- Known resistance to proposed new HIV regimen or components of regimen.
- Requirement for drug therapy with known contraindication with proposed new antiretroviral therapy (see Prohibited and Precautionary Medications below)
- Pregnancy or breast feeding.
- Liver enzyme abnormalities on screening. Patients who have symptomatic Grade 3 elevations of total bilirubin, AST, ALT, or alkaline phosphatase or Grade > 3 elevations of total bilirubin, AST, ALT, or alkaline phosphatase will be excluded. Patients who have asymptomatic grade 3 elevations of total bilirubin, AST, ALT, or alkaline phosphatase may be included in the study at the discretion of the primary physician in consultation with the principal or senior investigator. Patients with grade 3 elevations of liver function tests who are co-infected with hepatitis B or hepatitis C may be included in the study at the discretion of the primary care physician in consultation with the primary or senior investigator provided that they do not have signs or symptoms of clinical hepatitis. Signs of clinical hepatitis include: icterus, abdominal tenderness and hepatosplenomegaly. Symptoms of clinical hepatitis include: fever, abdominal pain, anorexia, nausea, vomiting, fatigue, malaise, and myalgia.
- Decreased creatinine clearance at the time of screening. Patients with a creatinine clearance of <50mL/min as calculated by the Cockcroft-Gault method should be excluded from study entry. The Cockcroft-Gault method is defined on page 33.
- Other Grade ≥3 lab abnormalities. For any other laboratory abnormalities of grade 3 or higher, patients may be included or excluded from the study at the discretion of the primary care physician in consultation with the primary or senior investigator.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Cincinnati AIDS Clinical Trials Unit
Cincinnati, Ohio, 45267
About this study
The purposes of this study are:
- To understand whether the use of HIV therapy in persons with more advanced HIV disease results in greater side effects.
- To determine whether these side effects can be related to greater activation of the immune system.
Read the detailed description
- To compare the incidence and severity of self-reported symptoms in persons with CD4 counts <100 cells/mm3 versus those with CD4 counts ≥ 100 cells/mm3 who are initiating antiretroviral therapy.
- To determine the relationship between self-reported symptoms and levels of T cells, HIV RNA, activation marker cytokines including TNF-α, IFN-γ, IL-2, IL-4, IL-6, IL-10 and other cytokines as measured before and after the initiation of antiretroviral therapy.
- To determine the relationship between antiretroviral drug trough levels (estimated drug concentrations) and the incidence and severity of self-reported symptoms in persons initiating antiretroviral therapy.
- To determine the relationship between adverse events and immunological status as evidenced by lymphocyte counts and activation marker cytokine levels.
- To determine the relationship between clinical events and immunological status as evidenced by lymphocyte counts and activation marker cytokine levels.
- Conditions
- HIV Infections
- Being tested
- Truvada (tenofovir/emtricitabine), Kaletra (lopinavir/ritonavir)
- Keywords
- HIV, immune reconstitution, treatment naive
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Truvada (tenofovir/emtricitabine)Drug
Also called Truvada
Tenofovir/emtricitabine fixed dose combination once daily
Kaletra (lopinavir/ritonavir)Drug
Also called Kaletra
Lopinavir/ritonavir 400/100 mg twice daily
| Study group | Role | What they receive |
|---|---|---|
| Truvada/Kaletra CD4<100 | Other | All participants were treated but at baseline by design were divided based upon their CD4 count at baseline measurement. Group with CD4<100 cells/cu mm Receives: Drug: Truvada (tenofovir/emtricitabine); Drug: Kaletra (lopinavir/ritonavir) |
| Truvada/Kaletra CD4>/=100 | Other | All participants were treated but at baseline by design were divided based upon their CD4 count at baseline measurement. Group with CD4>/=100 cells/cu mm Receives: Drug: Truvada (tenofovir/emtricitabine); Drug: Kaletra (lopinavir/ritonavir) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom Score
AIDS Clinical Trials Group Symptom Summary Score (20 item scale with severity from 0-4); Severity scale, 0=absent, 1=is least severe and 4 is most severe. Minimum score = 0 units on scale. Maximum score = 80 units on scale.
Measured: Week 4
Secondary outcomes (10)
SF-12 Physical Capacity Score
Measure of physical function out of 100. Lower score means less physical capacity.
Measured: 4 weeks
SF-12 Mental Capacity Score
Measure of mental functioning where lower is better out of a scale of 100.
Measured: 4 weeks
IL-1 Beta
Cytokine IL-1 beta measurement by Luminex multiplex assay in picograms/mL, dynamic range 0.13-2000 pg/mL
Measured: 4 weeks
IL-4
Interleukin-4 measured by Luminex multiplex assay in picograms/mL, dynamic range 0.13-2000 pg/mL
Measured: 4 weeks
IL-6
Interleukin 6 measured by Luminex multiplex assay in picograms/mL, dynamic range 0.13-2000 pg/mL
Measured: 4 weeks
IL-7
Interleukin 7 measured by Luminex multiplex assay in picograms/mL, dynamic range 0.13-2000 pg/mL
Measured: 4 weeks
IL-8
Interleukin 8 measured by Luminex multiplex assay in picograms/mL, dynamic range 0.13-2000 pg/mL
Measured: 4 weeks
IL-10
Interleukin 10 measured by Luminex multiplex assay in picograms/mL, dynamic range 0.13-2000 pg/mL
Measured: 4 weeks
TNF Alpha
Tumor Necrosis Factor Alpha - measured by Luminex multiplex assay in picograms/mL, dynamic range 0.13-2000 pg/mL
Measured: 4 weeks
INF Gamma
Interferon gamma measured by Luminex multiplex assay in picograms/mL, dynamic range 0.13-2000 pg/mL
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2009 (estimated)
- Study startOct 2005
- Primary completionSep 2009
- Study completionMar 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 HIV InfectionsStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe 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
- Non-randomised
- Intervention model
- Single group
- Model description
- All participants received truvada and kaletra in this trial
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott, Gilead Sciences
- Responsible party
- Principal investigator, Carl J. Fichtenbaum, University of Cincinnati
- Investigators
- Carl J Fichtenbaum, MD, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00885664
- Sponsor's protocol ID
- IDC 30
- Status last verified
- Jul 2022
- First submitted
- 20 Apr 2009
- Last updated
- 10 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Reconstitution as a Determinant of Adverse Effects to New Antiretroviral Therapy in Persons With Advanced HIV Infection
- ClinicalTrials.gov ID
- NCT00885664
- Acronym / sponsor ID
- IDC 30
- Conditions
- HIV Infections
- Keywords
- HIV, immune reconstitution, treatment naive
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Collaborators
- Abbott, Gilead Sciences
- Study start
- Oct 2005
- Primary completion
- Sep 2009 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 22 Apr 2009 (estimated)
- Results
- Posted 10 Aug 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purposes of this study are:
- To understand whether the use of HIV therapy in persons with more advanced HIV disease results in greater side effects.
- To determine whether these side effects can be related to greater activation of the immune system.
Detailed description
- To compare the incidence and severity of self-reported symptoms in persons with CD4 counts <100 cells/mm3 versus those with CD4 counts ≥ 100 cells/mm3 who are initiating antiretroviral therapy.
- To determine the relationship between self-reported symptoms and levels of T cells, HIV RNA, activation marker cytokines including TNF-α, IFN-γ, IL-2, IL-4, IL-6, IL-10 and other cytokines as measured before and after the initiation of antiretroviral therapy.
- To determine the relationship between antiretroviral drug trough levels (estimated drug concentrations) and the incidence and severity of self-reported symptoms in persons initiating antiretroviral therapy.
- To determine the relationship between adverse events and immunological status as evidenced by lymphocyte counts and activation marker cytokine levels.
- To determine the relationship between clinical events and immunological status as evidenced by lymphocyte counts and activation marker cytokine levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- All participants received truvada and kaletra in this trial
| Arm | Type | Receives |
|---|---|---|
| Truvada/Kaletra CD4<100 | Other | Drug: Truvada (tenofovir/emtricitabine), Drug: Kaletra (lopinavir/ritonavir)All participants were treated but at baseline by design were divided based upon their CD4 count at baseline measurement. Group with CD4<100 cells/cu mm |
| Truvada/Kaletra CD4>/=100 | Other | Drug: Truvada (tenofovir/emtricitabine), Drug: Kaletra (lopinavir/ritonavir)All participants were treated but at baseline by design were divided based upon their CD4 count at baseline measurement. Group with CD4>/=100 cells/cu mm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > 18 years
- Diagnosis of HIV infection.
- Naive to antiretroviral therapy OR no use of antiretrovirals for ≥ 6 months.
Key exclusion criteria (8 listed)
- Blinded drug treatment.
- Active untreated serious infection within 14 days of enrollment that in the opinion of the investigator would affect the subject's participation and/or safety in the study.
- Known resistance to proposed new HIV regimen or components of regimen.
- Requirement for drug therapy with known contraindication with proposed new antiretroviral therapy (see Prohibited and Precautionary Medications below)
- Pregnancy or breast feeding.
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 |
|---|---|---|
| Truvada (tenofovir/emtricitabine)Also: TruvadaTenofovir/emtricitabine fixed dose combination once daily | Drug | Truvada/Kaletra CD4<100, Truvada/Kaletra CD4>/=100 |
| Kaletra (lopinavir/ritonavir)Also: KaletraLopinavir/ritonavir 400/100 mg twice daily | Drug | Truvada/Kaletra CD4<100, Truvada/Kaletra CD4>/=100 |
Primary outcome
Symptom Score
Time frame: Week 4
AIDS Clinical Trials Group Symptom Summary Score (20 item scale with severity from 0-4); Severity scale, 0=absent, 1=is least severe and 4 is most severe. Minimum score = 0 units on scale. Maximum score = 80 units on scale.
10 secondary outcomes
SF-12 Physical Capacity Score
Time frame: 4 weeks
SF-12 Mental Capacity Score
Time frame: 4 weeks
IL-1 Beta
Time frame: 4 weeks
IL-4
Time frame: 4 weeks
IL-6
Time frame: 4 weeks
IL-7
Time frame: 4 weeks
IL-8
Time frame: 4 weeks
IL-10
Time frame: 4 weeks
TNF Alpha
Time frame: 4 weeks
INF Gamma
Time frame: 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2022.
- 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.
Carl J Fichtenbaum, MD principal investigator
University of Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Truvada (tenofovir/emtricitabine) and Kaletra (lopinavir/ritonavir) in people with HIV Infections, run by University of Cincinnati at 1 site in United States.
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 8 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 10 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 10 Aug 2022). 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?
Symptom Score (time frame: Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Aug 2022.