HIV InfectionsPhase 3NCT00002220
Indinavir Plus Efavirenz Plus Adefovir Dipivoxil in HIV-Infected Patients Who Have Not Had Success With Nelfinavir
A Phase 3 study testing Indinavir sulfate, Efavirenz and Levocarnitine in people with HIV Infections, run by Merck Sharp & Dohme LLC at 11 sites in United States.
Trial summary
The purpose of this study is to compare the effectiveness of giving indinavir plus efavirenz plus adefovir dipivoxil to patients who have failed treatment with nelfinavir and patients who have never taken a protease inhibitor (PI). Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Indinavir sulfate, Efavirenz and Levocarnitine
- How many people
- 120 participants
- Where
- 11 sitesUnited States
- Study dates
- Start not givento 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients must have:
- Serologically documented HIV infection.
- Baseline CD4 count greater than or equal to 50 cells and vRNA greater than or equal to 10,000 copies/ml.
- Parental consent for patients under 18.
- Nelfinavir-Failure Group:
- Must have protease inhibitor experience solely with nelfinavir and be considered drug-adherent.
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- Must be candidate for changing therapy because of virologic failure and be receiving nelfinavir at entry (at least 16 weeks of nelfinavir plus NRTI therapy with at least a 10-fold decline in vRNA due to nelfinavir therapy and a subsequent increase toward the patient's baseline vRNA of at least 10-fold).
- Control Group:
- Must have received any combination of currently licensed nucleoside reverse transcriptase inhibitors for at least 16 weeks.
- Must be naive to efavirenz, adefovir dipivoxil, and other NRTI's.
Who cannot join
- Prior Medication:
- Excluded:
- Control group:
- Prior efavirenz, adefovir dipivoxil, or other non-nucleoside reverse transcriptase inhibitors.
- Required:
- Nelfinavir-failure patients:
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- At least 16 weeks of nelfinavir.
- Control group:
- At least 16 weeks of any combination of currently licensed nucleoside reverse transcriptase inhibitors.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Johns Hopkins Hosp
Baltimore, Maryland, 212876220
Massachusetts Gen Hosp
Boston, Massachusetts, 02114
Rush Presbyterian Saint Lukes Med Ctr
Chicago, Illinois, 606123832
Oaklawn Physicians Group
Dallas, Texas, 75219
Hawaii AIDS Clinical Trial Unit
Honolulu, Hawaii, 96816
LAC / USC Med Ctr / Infectious Diseases
Los Angeles, California, 90033
Vanderbilt Clinic
Nashville, Tennessee, 37212
Yale Univ / AIDS Clinical Trials Unit
New Haven, Connecticut, 06510
Columbia Presbyterian Hosp
New York, New York, 10032
AIDS TMT Unit / Univ Hosp
Stony Brook, New York, 117948153
Med Ctr of Delaware
Wilmington, Delaware, 19899
About this study
Official title: Multi-Center, Open-Label Study of the Effect of Indinavir, Efavirenz, and Adefovir Dipivoxil Combination Therapy in Patients Who Have Failed Nelfinavir
The purpose of this study is to compare the effectiveness of giving indinavir plus efavirenz plus adefovir dipivoxil to patients who have failed treatment with nelfinavir and patients who have never taken a protease inhibitor (PI). Effectiveness is measured by the number of patients who have a viral load (level of HIV in the blood) below 400 copies/ml after 48 weeks of treatment.
Read the detailed description
In this open-label, nonrandomized study, 120 HIV-infected patients are stratified into two groups: failed nelfinavir vs protease inhibitor-naive. All patients receive indinavir plus efavirenz plus adefovir dipivoxil plus and L-carnitine, orally. Plasma vRNA is measured every 4 weeks until Week 16, then every 8 weeks for the remainder of the 48-week study.
- Conditions
- HIV Infections
- Being tested
- Indinavir sulfate, Efavirenz, Levocarnitine, Adefovir dipivoxil
- Keywords
- Drug Resistance, Drug Therapy, Combination, Antiviral Agents, HIV Protease Inhibitors, Indinavir, RNA, Viral, Adenine, 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.
Indinavir sulfateDrug
EfavirenzDrug
LevocarnitineDrug
Adefovir dipivoxilDrug
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.
- More trials run by Merck Sharp & Dohme LLCThe 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 3
- Primary purpose
- Treatment
- Enrolment
- 120 participants
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002220
- Sponsor's protocol ID
- 246N
- Other IDs
- 075-00
- Status last verified
- Jun 1999
- 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
- Multi-Center, Open-Label Study of the Effect of Indinavir, Efavirenz, and Adefovir Dipivoxil Combination Therapy in Patients Who Have Failed Nelfinavir
- ClinicalTrials.gov ID
- NCT00002220
- Acronym / sponsor ID
- 246N
- Conditions
- HIV Infections
- Keywords
- Drug Resistance, Drug Therapy, Combination, Antiviral Agents, HIV Protease Inhibitors, Indinavir, RNA, Viral, Adenine, efavirenz
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (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 compare the effectiveness of giving indinavir plus efavirenz plus adefovir dipivoxil to patients who have failed treatment with nelfinavir and patients who have never taken a protease inhibitor (PI). Effectiveness is measured by the number of patients who have a viral load (level of HIV in the blood) below 400 copies/ml after 48 weeks of treatment.
Detailed description
In this open-label, nonrandomized study, 120 HIV-infected patients are stratified into two groups: failed nelfinavir vs protease inhibitor-naive. All patients receive indinavir plus efavirenz plus adefovir dipivoxil plus and L-carnitine, orally. Plasma vRNA is measured every 4 weeks until Week 16, then every 8 weeks for the remainder of the 48-week study.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Serologically documented HIV infection.
- Baseline CD4 count greater than or equal to 50 cells and vRNA greater than or equal to 10,000 copies/ml.
- Parental consent for patients under 18.
- Must have protease inhibitor experience solely with nelfinavir and be considered drug-adherent.
- Must be candidate for changing therapy because of virologic failure and be receiving nelfinavir at entry (at least 16 weeks of nelfinavir plus NRTI therapy with at least a 10-fold decline in vRNA due to nelfinavir therapy and a subsequent increase toward the patient's baseline vRNA of at least 10-fold).
Key exclusion criteria (9 listed)
- Prior efavirenz, adefovir dipivoxil, or other non-nucleoside reverse transcriptase inhibitors.
- At least 16 weeks of nelfinavir.
- At least 16 weeks of any combination of currently licensed nucleoside reverse transcriptase inhibitors.
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 |
|---|---|---|
| Indinavir sulfate | Drug | – |
| Efavirenz | Drug | – |
| Levocarnitine | Drug | – |
| Adefovir dipivoxil | 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.
11 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 Indinavir sulfate, Efavirenz and Levocarnitine in people with HIV Infections, run by Merck Sharp & Dohme LLC at 11 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 10 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: 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 11 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?
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.