HIV InfectionsPhase 4NCT00426296
SHARE: Simple HAART With Abacavir, Reyataz, and Epivir
A Phase 4 study testing atazanavir (Reyataz) and ritonavir (Norvir) in people with HIV Infections and Lipodystrophy, run by Clinical Alliance for Research & Education - Infectious Diseases, LLC. at 1 site in United States.
Trial summary
SHARE: Simple HAART with Abacavir, Reyataz, and Epivir Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections, Lipodystrophy
- What is being tested?
- atazanavir (Reyataz) and ritonavir (Norvir)
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to not given
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- Adult, Older adult
Who may be able to join
- Currently taking abacavir/lamivudine (Epzicom) in combination with atazanavir (Reyataz) boosted with ritonavir (Norvir) as first antiretroviral regimen
- Viral load <50 copies/ml
Who cannot join
- Viral load >50 copies/ml
- Having taken more than one antiretroviral regimen
Trial locations and contacts
1 site in 1 country.
Richard A. Elion, MD contact
United States1 site, 1 recruiting
- Recruiting
Whitman-Walker Clinic
Washington D.C., District of Columbia
Richard Elion, MD, drrelion@aol.com
Richard A Elion, MD
About this study
Official title: An Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of a Fixed-Dose Combination of Abacavir 600 mg/Lamivudine 300 mg Once-Daily in Combination With Atazanavir 300 mg + Ritonavir 100 mg Once-Daily in Antiretroviral-Naïve HIV-1 Infected Subjects With Continuing Evaluation of Abacavir/Lamivudine Plus Atazanavir 400 mg for Maintenance Over an Additional 48 Weeks
SHARE: Simple HAART with Abacavir, Reyataz, and Epivir
Read the detailed description
Open-label, multicenter study of ABC/3TC + ATV in subjects who have completed at least 24 weeks of treatment on ABC/3TC+ATV/RTV as their first line regimen and have plasma HIV-1 RNA <50 copies/mL at entry
- Conditions
- HIV Infections, Lipodystrophy
- Being tested
- atazanavir (Reyataz), ritonavir (Norvir)
- Keywords
- HIV, Reyataz, atazanavir, Norvir, ritonavir, Boosted, Lipodystrophy, Treatment Experienced
- Medical subject headings
- HIV Infections, Lipodystrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
atazanavir (Reyataz)Drug
ritonavir (Norvir)Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2007 (estimated)
- Study startAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Clinical Alliance for Research & Education - Infectious Diseases, LLC.
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Investigators
- Richard A Elion, MD, Principal investigator, Whitman-Walker Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00426296
- Sponsor's protocol ID
- COL102060
- Status last verified
- Oct 2007
- First submitted
- 23 Jan 2007
- Last updated
- 1 Nov 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of a Fixed-Dose Combination of Abacavir 600 mg/Lamivudine 300 mg Once-Daily in Combination With Atazanavir 300 mg + Ritonavir 100 mg Once-Daily in Antiretroviral-Naïve HIV-1 Infected Subjects With Continuing Evaluation of Abacavir/Lamivudine Plus Atazanavir 400 mg for Maintenance Over an Additional 48 Weeks
- ClinicalTrials.gov ID
- NCT00426296
- Acronym / sponsor ID
- COL102060
- Conditions
- HIV Infections, Lipodystrophy
- Keywords
- HIV, Reyataz, atazanavir, Norvir, ritonavir, Boosted, Lipodystrophy, Treatment Experienced
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Clinical Alliance for Research & Education - Infectious Diseases, LLC.University, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Aug 2006
- First posted
- 24 Jan 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
SHARE: Simple HAART with Abacavir, Reyataz, and Epivir
Detailed description
Open-label, multicenter study of ABC/3TC + ATV in subjects who have completed at least 24 weeks of treatment on ABC/3TC+ATV/RTV as their first line regimen and have plasma HIV-1 RNA <50 copies/mL at entry
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Currently taking abacavir/lamivudine (Epzicom) in combination with atazanavir (Reyataz) boosted with ritonavir (Norvir) as first antiretroviral regimen
- Viral load <50 copies/ml
Key exclusion criteria (2 listed)
- Viral load >50 copies/ml
- Having taken more than one antiretroviral regimen
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 |
|---|---|---|
| atazanavir (Reyataz) | Drug | – |
| ritonavir (Norvir) | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2007.
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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.
Richard A. Elion, MD contact
Richard A Elion, MD principal investigator
Whitman-Walker Clinic
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 atazanavir (Reyataz) and ritonavir (Norvir) in people with HIV Infections and Lipodystrophy, run by Clinical Alliance for Research & Education - Infectious Diseases, LLC. 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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 1 Nov 2007. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Richard A. Elion, MD (drrelion@aol.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 1 Nov 2007.