HIV InfectionsPhase 3NCT00002362
A Comparison of Emtricitabine and Abacavir Used in a Three-Drug Combination in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs
A Phase 3 study testing Abacavir sulfate, Efavirenz and Emtricitabine in people with HIV Infections, run by Triangle Pharmaceuticals at 10 sites in United States.
Trial summary
This study will look at whether emtricitabine is as safe and effective as abacavir (ABC) when taken with stavudine (d4T) and efavirenz (EFV) in patients who have never taken anti-HIV drugs. 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?
- Abacavir sulfate, Efavirenz and Emtricitabine
- How many people
- Not given
- Where
- 10 sitesUnited States
- Study dates
- Aug 1999to not given
- Phase
- Phase 3
- 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
- You may be eligible if you:
- Are HIV-positive and generally healthy.
- Have a viral load of 5,000 copies/ml or more.
- Have CD4 cell counts of 200 cells/mm3 or more.
- Are age 18 or older.
- Agree to practice sexual abstinence or use effective barrier methods of birth control (such as condoms).
Who cannot join
- You will not be eligible if you:
- Have ever taken anti-HIV drugs for 3 days or more.
- Have had certain AIDS-related infections.
- Have had severe diarrhea within the past 30 days.
- Are unable to eat at least 1 meal a day due to nausea, vomiting, or stomach pain.
- Are being treated for active tuberculosis (TB).
Show all 9Show fewer
- Are pregnant or breast-feeding.
- Use illegal drugs or alcohol that make it difficult for you to take study drugs or keep clinic appointments.
- Are taking certain medications, or have certain other conditions or diseases (see the technical summary for more detail).
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Northstar Med Clinic
Chicago, Illinois, 60657
Univ of Texas Southwestern Med Ctr of Dallas
Dallas, Texas, 75235
Gary Richmond MD
Fort Lauderdale, Florida, 33316
Houston Clinical Research Network
Houston, Texas, 77006
Univ of Texas / Med School at Houston
Houston, Texas, 77030
North Shore Univ Hosp / Div of Infectious Diseases
Manhasset, New York, 11030
Ctr for AIDS Research / Education and Service (CARES)
Sacramento, California, 95814
Univ of Texas Health Sciences Ctr
San Antonio, Texas, 78284
San Francisco Veterans Administration Med Ctr
San Francisco, California, 94121
South Jersey Infectious Diseases Inc
Somers Point, New Jersey, 08244
About this study
Official title: A Randomized, Open-Label Superiority Trial Comparing Emtricitabine to Abacavir Within a Triple Drug Combination in Antiretroviral-Drug Naive HIV-1 Infected Patients
This study will look at whether emtricitabine is as safe and effective as abacavir (ABC) when taken with stavudine (d4T) and efavirenz (EFV) in patients who have never taken anti-HIV drugs.
Read the detailed description
Patients are randomized to receive open-label emtricitabine or ABC in combination with stavudine and efavirenz. Viral load and CD4+ cell counts are compared at Weeks 24 and 48. Patients are followed for 48 weeks.
- Conditions
- HIV Infections
- Being tested
- Abacavir sulfate, Efavirenz, Emtricitabine, Stavudine
- Keywords
- Dideoxynucleosides, Drug Therapy, Combination, Stavudine, Reverse Transcriptase Inhibitors, abacavir, efavirenz
- 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 sulfateDrug
EfavirenzDrug
EmtricitabineDrug
StavudineDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
- Study startAug 1999
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 3
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Triangle Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002362
- Sponsor's protocol ID
- 298B
- Other IDs
- FTC-301
- Status last verified
- Mar 2000
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label Superiority Trial Comparing Emtricitabine to Abacavir Within a Triple Drug Combination in Antiretroviral-Drug Naive HIV-1 Infected Patients
- ClinicalTrials.gov ID
- NCT00002362
- Acronym / sponsor ID
- 298B
- Conditions
- HIV Infections
- Keywords
- Dideoxynucleosides, Drug Therapy, Combination, Stavudine, Reverse Transcriptase Inhibitors, abacavir, efavirenz
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Suspended
- Lead sponsor
- Triangle PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Aug 1999
- First posted
- 31 Aug 2001 (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.
This study will look at whether emtricitabine is as safe and effective as abacavir (ABC) when taken with stavudine (d4T) and efavirenz (EFV) in patients who have never taken anti-HIV drugs.
Detailed description
Patients are randomized to receive open-label emtricitabine or ABC in combination with stavudine and efavirenz. Viral load and CD4+ cell counts are compared at Weeks 24 and 48. Patients are followed for 48 weeks.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Are HIV-positive and generally healthy.
- Have a viral load of 5,000 copies/ml or more.
- Have CD4 cell counts of 200 cells/mm3 or more.
- Are age 18 or older.
- Agree to practice sexual abstinence or use effective barrier methods of birth control (such as condoms).
Key exclusion criteria (9 listed)
- Have ever taken anti-HIV drugs for 3 days or more.
- Have had certain AIDS-related infections.
- Have had severe diarrhea within the past 30 days.
- Are unable to eat at least 1 meal a day due to nausea, vomiting, or stomach pain.
- Are being treated for active tuberculosis (TB).
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 sulfate | Drug | – |
| Efavirenz | Drug | – |
| Emtricitabine | Drug | – |
| Stavudine | 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 24 Jun 2005.
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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.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Abacavir sulfate, Efavirenz and Emtricitabine in people with HIV Infections, run by Triangle Pharmaceuticals at 10 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 6 inclusion and 9 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: paused, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 24 Jun 2005.