HIV InfectionPhase 4NCT00038506

Study Of Investigational Regimen Combining FDA Approved HIV Drugs In HIV Subjects Experiencing Early Virologic Failure

A Phase 4 study testing abacavir/lamivudine/zidovudine and tenofovir in people with HIV Infection, run by ViiV Healthcare at 27 sites in United States.

Completed

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

Official record

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Trial summary

This study is a 48-week study to evaluate the efficacy and safety of an investigational regimen combining FDA approved HIV drugs in antiretroviral-experienced subjects failing on their first highly active antiretroviral therapy regimen. 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?: abacavir/lamivudine/zidovudine and tenofovir
How many people: 100 participants
Where: 27 sitesUnited States
Study dates: Mar 2002to Aug 2004
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
No healthy volunteers
Adult, Older adult

Who may be able to join

Currently on an initial HAART (highly active antiretroviral therapy) regimen of 3TC/ZDV or 3TC/d4T and a PI (protease inhibitor) -boosted or unboosted- or NNRTI (non-nucleoside reverse transcriptase inhibitor).
Plasma HIV - 1 RNA was <400 copies/ml on at least 2 documented occasions prior to viral rebound.
Have a plasma HIV - 1 RNA value >400 copies/ml and <10,000 copies/ml on 2 documented successive occasions (including screen) separated by at least 2 weeks.
A CD4+ lymphocyte count less than or equal to 100.

Who cannot join

Have not taken Abacavir (ZIAGEN or TRIZIVIR) or tenofovir (VIREAD) previously.
Have not had an AIDS defining illness within 30 days of screen.
Pregnant or breast-feeding.
Specified viral genotypes upon screening.
And other inclusion or exclusion criteria to be evaluated by the physician.

Trial locations and contacts

27 sites in 1 country.

City, postcode or hospital

27 sites in 1 country

United States27 sites

GSK Investigational Site
Arlington, Texas, 76015
GSK Investigational Site
Atlanta, Georgia, 30309
GSK Investigational Site
Berkeley, Michigan, 48072
GSK Investigational Site
Chicago, Illinois, 60657
GSK Investigational Site
Dallas, Texas, 75208
GSK Investigational Site
Dallas, Texas, 75216
GSK Investigational Site
Dallas, Texas, 75246
GSK Investigational Site
Decatur, Georgia, 30033
GSK Investigational Site
Fort Lauderdale, Florida, 33145
GSK Investigational Site
Green Bay, Wisconsin, 54301
GSK Investigational Site
Houston, Texas, 77004
GSK Investigational Site
Jacksonville, Florida, 32206
GSK Investigational Site
Lafayette, Indiana, 47904
GSK Investigational Site
Lake Worth, Florida, 33463
GSK Investigational Site
Los Angeles, California, 90027
GSK Investigational Site
Maywood, Illinois, 60153
GSK Investigational Site
Miami, Florida, 33136
GSK Investigational Site
Miami Beach, Florida, 33139
GSK Investigational Site
New York, New York, 10014
GSK Investigational Site
North Miami, Florida, 33161
GSK Investigational Site
Orlando, Florida, 32804
GSK Investigational Site
San Rafael, California, 94903
GSK Investigational Site
Seattle, Washington, 98104
GSK Investigational Site
Tallahassee, Florida, 32303
GSK Investigational Site
The Bronx, New York, 10461
GSK Investigational Site
Tulsa, Oklahoma, 74114
GSK Investigational Site
Valhalla, New York, 10595

Other trials in United States

About this study

Official title: A Phase IV, Open-label, Multicenter Study of Treatment With TRIZIVIR (Abacavir 300mg/Lamivudine 150mg/Zidovudine 300mg) Twice Daily and Tenofovir 300mg Once-daily for 48 Weeks in HIV-infected Subjects Experiencing Early Virologic Failure (ZIAGEN Intensification Protocol)

Conditions: HIV Infection
Being tested: abacavir/lamivudine/zidovudine, tenofovir
Keywords: HIV-1 TRIZIVIR Tenofovir
Medical subject headings: HIV Infections

What participants receive

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

abacavir/lamivudine/zidovudineDrug
tenofovirDrug
Also called abacavir/lamivudine/zidovudine

What is being measured

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

HIV viral load response at 48 weeks as measured by proportion of subjects with undetectable viral load.
Measured: 48 weeks

Secondary outcomes (1)

Safety Viral load response at 24 weeks Change in T-cell count Resistance Health outcomes
Measured: 24 weeks

Timeline

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

Mar 2002Aug 2004

First posted3 Jun 2002 (estimated)
Study startMar 2002
Primary completionAug 2004
Study completionAug 2004

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HIV InfectionStudies of the same condition, open and under way.
More trials run by ViiV HealthcareThe 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
Masking: None (open label)
Enrolment: 100 participants

IDs, dates and publications

ClinicalTrials.gov ID: NCT00038506
Sponsor's protocol ID: ESS 30005
Status last verified: Oct 2010
First submitted: 31 May 2002
Last updated: 8 Apr 2015
Results posted: 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

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Trial Phase: Syndemic Adapted Medly Uganda
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HIV, Substance Use Disorder

All HIV Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase IV, Open-label, Multicenter Study of Treatment With TRIZIVIR (Abacavir 300mg/Lamivudine 150mg/Zidovudine 300mg) Twice Daily and Tenofovir 300mg Once-daily for 48 Weeks in HIV-infected Subjects Experiencing Early Virologic Failure (ZIAGEN Intensification Protocol)
ClinicalTrials.gov ID: NCT00038506
Acronym / sponsor ID: ESS 30005
Conditions: HIV Infection
Keywords: HIV-1 TRIZIVIR Tenofovir
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants
Lead sponsor: ViiV HealthcareIndustry (pharma, biotech, devices)
Study start: Mar 2002
Primary completion: Aug 2004 (actual)
Study completion: Aug 2004 (actual)
First posted: 3 Jun 2002 (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.

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
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Currently on an initial HAART (highly active antiretroviral therapy) regimen of 3TC/ZDV or 3TC/d4T and a PI (protease inhibitor) -boosted or unboosted- or NNRTI (non-nucleoside reverse transcriptase inhibitor).
Plasma HIV - 1 RNA was <400 copies/ml on at least 2 documented occasions prior to viral rebound.
Have a plasma HIV - 1 RNA value >400 copies/ml and <10,000 copies/ml on 2 documented successive occasions (including screen) separated by at least 2 weeks.
A CD4+ lymphocyte count less than or equal to 100.

Key exclusion criteria (5 listed)

Have not taken Abacavir (ZIAGEN or TRIZIVIR) or tenofovir (VIREAD) previously.
Have not had an AIDS defining illness within 30 days of screen.
Pregnant or breast-feeding.
Specified viral genotypes upon screening.
And other inclusion or exclusion criteria to be evaluated by the physician.

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
abacavir/lamivudine/zidovudine	Drug	–
tenofovirAlso: abacavir/lamivudine/zidovudine	Drug	–

Primary outcome

HIV viral load response at 48 weeks as measured by proportion of subjects with undetectable viral load.
Time frame: 48 weeks

1 secondary outcome

Safety Viral load response at 24 weeks Change in T-cell count Resistance Health outcomes
Time frame: 24 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2015.

Related trials for HIV Infection

Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder

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, MD study director

GlaxoSmithKline

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing abacavir/lamivudine/zidovudine and tenofovir in people with HIV Infection, run by ViiV Healthcare at 27 sites 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 5 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 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

HIV viral load response at 48 weeks as measured by proportion of subjects with undetectable viral load. (time frame: 48 weeks). 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 NCT00038506.

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 Apr 2015.