HIV InfectionsPhase 4RANNCT00762892
Raltegravir vs. Atazanavir in Combination With Truvada® for the Treatment of Antiretroviral naïve HIV Infected Patients
A Phase 4 study testing Raltegravir and truvada and Atazanavir, Norvir and Truvada in people with HIV Infections, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
This is a pilot that will evaluate two regimens for treating HIV infected patients that haven't been on treatment before. HIV/AIDS patients may have an increased risk of myocardial infarction and antiretroviral therapy used may contribute to this. 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?
- Raltegravir and truvada and Atazanavir, Norvir and Truvada
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Jan 2013
- 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
- Patients must be HIV-1 positive and naïve to HIV therapy.
- Patients must plan to participate and be available for the trial for the 96-week study period.
- Patients followed at Thomas Street Clinic.
- Patients must be over 18 years old.
Who cannot join
- Patients must not be pregnant or plan to become pregnant over the 96-week study period.
- Patients cannot be on a proton pump inhibitor.
- Patients cannot be undergoing treatment for active tuberculosis.
- Renal Insufficiency with a creatinine clearance < 50 ml/min/1.73 m2 by the MDRD GFR calculation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study--randomized, Prospective, Single Site Trial Evaluating Raltegravir vs. Atazanavir in Combination With Truvada® for the Treatment of Antiretroviral naïve HIV Infected Patients
This is a pilot that will evaluate two regimens for treating HIV infected patients that haven't been on treatment before. HIV/AIDS patients may have an increased risk of myocardial infarction and antiretroviral therapy used may contribute to this. We will evaluate virological, immunological and cardiovascular effects of two HIV treatment regimens.
Read the detailed description
We will check blood studies used to evaluate HIV patients response to therapy including CD4 count and HIV viral load test. We will check routine safety labs done on HIV patients and also check homocysteine levels and creatine kinase level. We will evaluate homocysteine and IL6 levels at baseline, week 48, and week 96.
- Conditions
- HIV Infections
- Being tested
- Raltegravir and truvada, Atazanavir, Norvir and Truvada
- Keywords
- Raltegravir, Integrase inhibitor, Protease inhibitor, Naive patients, HIV disease, Lipids, Treatment Naïve
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Raltegravir and truvadaDrug
Also called Truvada is tenofovir 300 mg and emtricitabine 200 mg
Raltegravir 400 mg po bid, truvada 1 tab q daily
Atazanavir, Norvir and TruvadaDrug
Also called Truvada is tenofovir 300 mg and emtricitabine 200 mg
Atazanavir 300 mg po q daily, Norvir 100 mg po q daily and Truvada 1 tablet po q daily
| Study group | Role | What they receive |
|---|---|---|
| Raltegravir | Active comparator | Raltegravir in combination with truvada (tenofovir and emtricitabine) Receives: Drug: Raltegravir and truvada |
| Atazanavir | Active comparator | Atazanavir, low dose ritonavir, and truvada (tenofovir and emtricitabine) Receives: Drug: Atazanavir, Norvir and Truvada |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in CD4 Count at 48 Weeks
Measured: Baseline and 48 weeks
Change From Baseline in Log HIV Viral Load at 48 Weeks
Measured: Baseline and 48 weeks
Secondary outcomes (3)
Change From Baseline in Lipids at 48 Weeks
Measured: Baseline and 48 weeks
Change From Baseline in Interleukin-6 (IL-6) at 48 Weeks
Measured: Baseline and 48 weeks
Change From Baseline in Homocysteine at 6 Months
Measured: Baseline and 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2008 (estimated)
- Study startJan 2009
- Primary completionDec 2012
- Study completionJan 2013
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 The University of Texas Health Science Center, HoustonThe 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
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Tanvir K. Bell, MD, The University of Texas Health Science Center, Houston
- Investigators
- Tanvir K Bell, MD, Principal investigator, UT-Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00762892
- Sponsor's protocol ID
- raltegravir atazanavir naive
- Acronym
- RAN
- Status last verified
- Dec 2014
- First submitted
- 26 Sep 2008
- Last updated
- 5 Jan 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study--randomized, Prospective, Single Site Trial Evaluating Raltegravir vs. Atazanavir in Combination With Truvada® for the Treatment of Antiretroviral naïve HIV Infected Patients
- ClinicalTrials.gov ID
- NCT00762892
- Acronym / sponsor ID
- RAN / raltegravir atazanavir naive
- Conditions
- HIV Infections
- Keywords
- Raltegravir, Integrase inhibitor, Protease inhibitor, Naive patients, HIV disease, Lipids, Treatment Naïve
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Jan 2009
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 30 Sep 2008 (estimated)
- Results
- Posted 5 Jan 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a pilot that will evaluate two regimens for treating HIV infected patients that haven't been on treatment before. HIV/AIDS patients may have an increased risk of myocardial infarction and antiretroviral therapy used may contribute to this. We will evaluate virological, immunological and cardiovascular effects of two HIV treatment regimens.
Detailed description
We will check blood studies used to evaluate HIV patients response to therapy including CD4 count and HIV viral load test. We will check routine safety labs done on HIV patients and also check homocysteine levels and creatine kinase level. We will evaluate homocysteine and IL6 levels at baseline, week 48, and week 96.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Raltegravir | Active comparator | Drug: Raltegravir and truvadaRaltegravir in combination with truvada (tenofovir and emtricitabine) |
| Atazanavir | Active comparator | Drug: Atazanavir, Norvir and TruvadaAtazanavir, low dose ritonavir, and truvada (tenofovir and emtricitabine) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients must be HIV-1 positive and naïve to HIV therapy.
- Patients must plan to participate and be available for the trial for the 96-week study period.
- Patients followed at Thomas Street Clinic.
- Patients must be over 18 years old.
Key exclusion criteria (4 listed)
- Patients must not be pregnant or plan to become pregnant over the 96-week study period.
- Patients cannot be on a proton pump inhibitor.
- Patients cannot be undergoing treatment for active tuberculosis.
- Renal Insufficiency with a creatinine clearance < 50 ml/min/1.73 m2 by the MDRD GFR calculation.
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 |
|---|---|---|
| Raltegravir and truvadaAlso: Truvada is tenofovir 300 mg and emtricitabine 200 mgRaltegravir 400 mg po bid, truvada 1 tab q daily | Drug | Raltegravir |
| Atazanavir, Norvir and TruvadaAlso: Truvada is tenofovir 300 mg and emtricitabine 200 mgAtazanavir 300 mg po q daily, Norvir 100 mg po q daily and Truvada 1 tablet po q daily | Drug | Atazanavir |
Primary outcome
Change From Baseline in CD4 Count at 48 Weeks
Time frame: Baseline and 48 weeks
Change From Baseline in Log HIV Viral Load at 48 Weeks
Time frame: Baseline and 48 weeks
3 secondary outcomes
Change From Baseline in Lipids at 48 Weeks
Time frame: Baseline and 48 weeks
Change From Baseline in Interleukin-6 (IL-6) at 48 Weeks
Time frame: Baseline and 48 weeks
Change From Baseline in Homocysteine at 6 Months
Time frame: Baseline and 48 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- open access journalLink provided by the sponsor.
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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.
Tanvir K Bell, MD principal investigator
UT-Houston
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 Raltegravir and truvada and Atazanavir, Norvir and Truvada in people with HIV Infections, run by The University of Texas Health Science Center, Houston 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 4 inclusion and 4 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 5 Jan 2015. 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 5 Jan 2015). 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?
Change From Baseline in CD4 Count at 48 Weeks (time frame: Baseline and 48 weeks). The study lists 2 primary outcomes in all. 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 5 Jan 2015.