HIV InfectionsPhase 2NCT00002225
A Study of Efavirenz in Combination With Stavudine and Didanosine
A Phase 2 study testing Efavirenz, Stavudine and Didanosine in people with HIV Infections, run by Dupont Merck at 5 sites in United States.
Trial summary
The purpose of this study is to see if it is safe and effective to give efavirenz plus stavudine plus didanosine to HIV-infected patients who have never received anti-HIV treatment. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Efavirenz, Stavudine and Didanosine
- How many people
- 60 participants
- Where
- 5 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 2
- 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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients must have:
- Documented HIV infection with plasma HIV-RNA greater than or equal to 10,000 copies/ml.
- A life expectancy of at least 12 months.
Who cannot join
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- Current bilateral peripheral neuropathy greater than or equal to Grade 2.
- Any clinically significant laboratory findings obtained during the screening evaluation (see laboratory values).
- Any clinically significant disease (other than HIV infection) or clinically significant findings during screening of medical history or physical examination.
- Any malignancy that requires systemic therapy.
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- Proven or suspected acute hepatitis due to any cause.
- Recurrent episodes of moderate to severe diarrhea, or vomiting lasting more than 4 days within 3 months prior to dosing.
- Active AIDS-defining opportunistic infection or disease.
- Concurrent Medication:
- Excluded:
- Astemizole, cisapride, clarithromycin, ketoconazole, itraconazole, midazolam, rifabutin, rifampin, terfenadine, thalidomide, triazolam, vincristine, zalcitabine.
- Patients with the following prior conditions are excluded:
- History of acute or chronic pancreatitis.
- Life expectancy less than 12 months.
- Difficulty in swallowing capsules/tablets.
- Hypersensitivity to any component of the formulation of efavirenz, stavudine, or didanosine.
- Prior Medication:
- Excluded:
- Any other experimental drug within 30 days of introducing study treatment.
- Vaccination within 3 weeks of screening visit.
- Interferon started within 30 days of initiating study treatment.
- Prior antiretroviral therapy.
- Risk Behavior:
- Excluded:
- Current alcohol or illicit drug use which would interfere with compliance with dosing schedule and protocol evaluations.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Carolinas Research Associates
Charlotte, North Carolina, 28207
AIDS Research Alliance - Chicago
Chicago, Illinois, 60657
North Shore AIDS Hosp / Division of Infectious Disease
Manhassett, New York, 11030
Univ of Rochester Med Ctr
Rochester, New York, 14642
The Whitman Walker Clinic
Washington D.C., District of Columbia, 20009
About this study
Official title: A Phase II, Open-Label, Multicenter Study to Characterize the Effectiveness and Safety of Efavirenz in Combination With Stavudine and Didanosine in Antiretroviral Therapy-Naive HIV-Infected Patients
The purpose of this study is to see if it is safe and effective to give efavirenz plus stavudine plus didanosine to HIV-infected patients who have never received anti-HIV treatment.
Read the detailed description
Patients will be given combination treatment with efavirenz, stavudine, and didanosine.
- Conditions
- HIV Infections
- Being tested
- Efavirenz, Stavudine, Didanosine
- Keywords
- Didanosine, Drug Therapy, Combination, Stavudine, Reverse Transcriptase Inhibitors, 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.
EfavirenzDrug
StavudineDrug
DidanosineDrug
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)
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 2
- Primary purpose
- Treatment
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Dupont Merck
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002225
- Sponsor's protocol ID
- 281D
- Other IDs
- DMP 266-044
- Status last verified
- Nov 1998
- 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 Phase II, Open-Label, Multicenter Study to Characterize the Effectiveness and Safety of Efavirenz in Combination With Stavudine and Didanosine in Antiretroviral Therapy-Naive HIV-Infected Patients
- ClinicalTrials.gov ID
- NCT00002225
- Acronym / sponsor ID
- 281D
- Conditions
- HIV Infections
- Keywords
- Didanosine, Drug Therapy, Combination, Stavudine, Reverse Transcriptase Inhibitors, efavirenz
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- Dupont MerckIndustry (pharma, biotech, devices)
- 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.
The purpose of this study is to see if it is safe and effective to give efavirenz plus stavudine plus didanosine to HIV-infected patients who have never received anti-HIV treatment.
Detailed description
Patients will be given combination treatment with efavirenz, stavudine, and didanosine.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Documented HIV infection with plasma HIV-RNA greater than or equal to 10,000 copies/ml.
- A life expectancy of at least 12 months.
Key exclusion criteria (26 listed)
- Current bilateral peripheral neuropathy greater than or equal to Grade 2.
- Any clinically significant laboratory findings obtained during the screening evaluation (see laboratory values).
- Any clinically significant disease (other than HIV infection) or clinically significant findings during screening of medical history or physical examination.
- Any malignancy that requires systemic therapy.
- Proven or suspected acute hepatitis due to any cause.
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 |
|---|---|---|
| Efavirenz | Drug | – |
| Stavudine | Drug | – |
| Didanosine | Drug | – |
Primary outcome
Not reported in the source record.
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 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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Efavirenz, Stavudine and Didanosine in people with HIV Infections, run by Dupont Merck at 5 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 3 inclusion and 26 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 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 5 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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.
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.