HIV InfectionsPhase 3NCT00006154
A Study to Evaluate the Use of a Protease Inhibitor and of Interleukin-2 (IL-2) in the Treatment of Early HIV Infection
A Phase 3 study testing Indinavir sulfate, Ritonavir and Abacavir sulfate in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 4 sites in Canada.
Trial summary
The purpose of this study is to look at the effectiveness of combination anti-HIV drug therapy (with protease inhibitors [PIs] or without) in patients with early HIV infections. This study also looks at whether a drug called interleukin-2 (IL-2) can boost the immune system of these patients. 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?
- Indinavir sulfate, Ritonavir and Abacavir sulfate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 4 sitesCanada
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients may be eligible for this study if they:
- Have been infected recently with HIV. This will be determined by certain lab tests.
- Are 18 years of age or older.
- Are able to swallow a large number of pills.
- Are willing to use barrier methods of birth control (such as condoms) during the study.
Who cannot join
- Patients will not be eligible for this study if they:
- Abuse drugs or alcohol.
- Have any condition that, in the opinion of the investigator, could impair their ability to participate in the study.
- Are breast-feeding or pregnant.
- Have received any prior anti-HIV drugs. (However, use of anti-HIV drugs to try to prevent infection more than 6 months prior to study entry is allowed.)
Trial locations and contacts
4 sites in 1 country.
Canada4 sites
Centre de traitment d'immunodeficience
Montreal, Quebec
Centre Hospitalier de la Universite de Montreal (CHUM)
Montreal, Quebec
Institut Thoracique de Montreal
Montreal, Quebec
Viridae Clinical Sciences / University of British Columbia
Vancouver, British Columbia
About this study
Official title: Randomized, Controlled, Open Label, Multi-Center Phase III Trial Comparing the Safety and Antiviral Activity of a Protease-Containing Regimen (d4T/ddI/IDV/RTV) Versus a Protease-Sparing Regimen (d4T/ddI/EFV) and the Ability of Interleukin-2 to Purge HIV From Latent Stores in Patients With Acute/Early HIV Infection
The purpose of this study is to look at the effectiveness of combination anti-HIV drug therapy (with protease inhibitors [PIs] or without) in patients with early HIV infections. This study also looks at whether a drug called interleukin-2 (IL-2) can boost the immune system of these patients.
Doctors are not sure which anti-HIV drug combination is best to use in patients who have early HIV infection and have never received anti-HIV treatment. PIs are anti-HIV drugs that decrease viral load (level of HIV in the blood). However, PIs can cause serious side effects in some patients. Doctors would like to know if a drug combination that does not contain a PI is just as good as one that contains PIs.
Read the detailed description
Studies have suggested that an antiretroviral drug regimen of the non-nucleoside agent efavirenz (EFV) in combination with two nucleoside analogues is effective at achieving maximal viral suppression. This provides an alternative treatment to that of the more toxic PI-containing regimen. This trial examines whether a nonPI regimen with EFV is more beneficial than a PI-containing regimen when each is used in combination with the same two nucleoside analogues. A second part of the study looks at whether the addition of IL-2 may offer immunologic benefits as a co-administered drug.
Patients are randomized to initiate antiretroviral therapy of a PI-based (stavudine/didanosine/ritonavir [RTV]/indinavir [IDV]) or nonPI-based (stavudine/didanosine/EFV) regimen. Within these treatment arms, they are stratified according to a positive or negative p24 antigen result. At Week 16, patients not achieving maximal viral suppression (lower than 50 copies/ml) have the option to add abacavir (ABC) or other drugs as intensification therapy. Those achieving virologic suppression (less than 50 copies/ml) are randomized either to receive IL-2 or not. At study entry, and after 12 months, tissue samples of CSF, lymph node, and genital secretions are obtained, with permission. Patients have physical exams, women of child-bearing potential have pregnancy tests, and blood samples are drawn at clinic visits 12-16 times a year over 3 years so that virologic and immunologic evaluations may be performed. Compensation for time and transportation is given.
- Conditions
- HIV Infections
- Being tested
- Indinavir sulfate, Ritonavir, Abacavir sulfate, Efavirenz, Stavudine
- Keywords
- Interleukin-2, Didanosine, Drug Therapy, Combination, Stavudine, HIV Protease Inhibitors, Ritonavir, Indinavir, Virus Latency, Reverse Transcriptase Inhibitors, Anti-HIV Agents, abacavir, efavirenz, Acute Infection
- 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
Also called IDV
400 mg tablets equaling 1600 mg daily
RitonavirDrug
Also called RTV
100 mg liquid capsules equaling 400 mg daily
Abacavir sulfateDrug
Also called ABC
300 mg capsules equaling 600 mg daily. Administration based on individual results after 16 weeks.
EfavirenzDrug
Also called DMP
200 mg capsules equaling 600 mg daily
StavudineDrug
Also called d4T
30-40 mg capsules equaling 60 or 80 mg daily
DidanosineDrug
Also called ddI
250-400 mg E.coated tablets equaling 250 or 400 mg daily
AldesleukinDrug
Also called Proleukin, IL-2
Subcutaneous injection equaling 15 x 10^6 IU daily dose. Administration based on individual results after 16 weeks and randomization.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Patients will receive combination antiretroviral therapy with a protease inhibitor Receives: Drug: Indinavir sulfate; Drug: Ritonavir; Drug: Abacavir sulfate; Drug: Didanosine; Drug: Aldesleukin |
| B | Active comparator | Patients will receive combination antiretroviral therapy without a protease inhibitor Receives: Drug: Abacavir sulfate; Drug: Efavirenz; Drug: Stavudine; Drug: Didanosine; Drug: Aldesleukin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Virologic: A. Plasma viral load B. Tissue viral load (CNS, lymphoid tissues, genital tract) C. HIV DNA (proviral) levels in circulating mononuclear cells D. Phenotypic and genotypic antiretroviral drug resistance
Measured: Throughout study
Immunologic: A. Evaluation of CD4, CD8, CD45RA, CD45RO phenotypes and defined activation markers B. Evaluation of the diversity and persistence of the T cell repertoire (CD4+, CD8+) in the circulation and lymphoid tissues
Measured: Throughout study
Immunologic: C. Functional CD4+ cellular assays (class II MHC tetramers) D. Thymic regeneration as studied by the exclusion circle assay E. Evolution of Western blot banding patterns F. Evolution of anti-HIV neutralizing antibody levels
Measured: Throughout study
Clinical: A. Minor opportunistic infections or AIDS-defining conditions B. Death C. Clinical or laboratory adverse events D. Evaluation of adherence to therapy E. Evaluation of lipodystrophy
Measured: Throughout study
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 National Institute of Allergy and Infectious Diseases (NIAID)The 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 165 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Rafick-Pierre Sekaly, Principal investigatorBrian Conway, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006154
- Sponsor's protocol ID
- AI-07-001
- Other IDs
- CTN #124, 11530
- Status last verified
- Sep 2013
- First submitted
- 7 Aug 2000
- Last updated
- 6 Sep 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Controlled, Open Label, Multi-Center Phase III Trial Comparing the Safety and Antiviral Activity of a Protease-Containing Regimen (d4T/ddI/IDV/RTV) Versus a Protease-Sparing Regimen (d4T/ddI/EFV) and the Ability of Interleukin-2 to Purge HIV From Latent Stores in Patients With Acute/Early HIV Infection
- ClinicalTrials.gov ID
- NCT00006154
- Acronym / sponsor ID
- AI-07-001
- Conditions
- HIV Infections
- Keywords
- Interleukin-2, Didanosine, Drug Therapy, Combination, Stavudine, HIV Protease Inhibitors, Ritonavir, Indinavir, Virus Latency
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- 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 look at the effectiveness of combination anti-HIV drug therapy (with protease inhibitors [PIs] or without) in patients with early HIV infections. This study also looks at whether a drug called interleukin-2 (IL-2) can boost the immune system of these patients.
Doctors are not sure which anti-HIV drug combination is best to use in patients who have early HIV infection and have never received anti-HIV treatment. PIs are anti-HIV drugs that decrease viral load (level of HIV in the blood). However, PIs can cause serious side effects in some patients. Doctors would like to know if a drug combination that does not contain a PI is just as good as one that contains PIs.
Detailed description
Studies have suggested that an antiretroviral drug regimen of the non-nucleoside agent efavirenz (EFV) in combination with two nucleoside analogues is effective at achieving maximal viral suppression. This provides an alternative treatment to that of the more toxic PI-containing regimen. This trial examines whether a nonPI regimen with EFV is more beneficial than a PI-containing regimen when each is used in combination with the same two nucleoside analogues. A second part of the study looks at whether the addition of IL-2 may offer immunologic benefits as a co-administered drug.
Patients are randomized to initiate antiretroviral therapy of a PI-based (stavudine/didanosine/ritonavir [RTV]/indinavir [IDV]) or nonPI-based (stavudine/didanosine/EFV) regimen. Within these treatment arms, they are stratified according to a positive or negative p24 antigen result. At Week 16, patients not achieving maximal viral suppression (lower than 50 copies/ml) have the option to add abacavir (ABC) or other drugs as intensification therapy. Those achieving virologic suppression (less than 50 copies/ml) are randomized either to receive IL-2 or not. At study entry, and after 12 months, tissue samples of CSF, lymph node, and genital secretions are obtained, with permission. Patients have physical exams, women of child-bearing potential have pregnancy tests, and blood samples are drawn at clinic visits 12-16 times a year over 3 years so that virologic and immunologic evaluations may be performed. Compensation for time and transportation is given.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Indinavir sulfate, Drug: Ritonavir, Drug: Abacavir sulfate, Drug: Didanosine, Drug: AldesleukinPatients will receive combination antiretroviral therapy with a protease inhibitor |
| B | Active comparator | Drug: Abacavir sulfate, Drug: Efavirenz, Drug: Stavudine, Drug: Didanosine, Drug: AldesleukinPatients will receive combination antiretroviral therapy without a protease inhibitor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Have been infected recently with HIV. This will be determined by certain lab tests.
- Are 18 years of age or older.
- Are able to swallow a large number of pills.
- Are willing to use barrier methods of birth control (such as condoms) during the study.
Key exclusion criteria (5 listed)
- Abuse drugs or alcohol.
- Have any condition that, in the opinion of the investigator, could impair their ability to participate in the study.
- Are breast-feeding or pregnant.
- Have received any prior anti-HIV drugs. (However, use of anti-HIV drugs to try to prevent infection more than 6 months prior to study entry is allowed.)
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 sulfateAlso: IDV400 mg tablets equaling 1600 mg daily | Drug | A |
| RitonavirAlso: RTV100 mg liquid capsules equaling 400 mg daily | Drug | A |
| Abacavir sulfateAlso: ABC300 mg capsules equaling 600 mg daily. Administration based on individual results after 16 weeks. | Drug | A, B |
| EfavirenzAlso: DMP200 mg capsules equaling 600 mg daily | Drug | B |
| StavudineAlso: d4T30-40 mg capsules equaling 60 or 80 mg daily | Drug | B |
| DidanosineAlso: ddI250-400 mg E.coated tablets equaling 250 or 400 mg daily | Drug | A, B |
| AldesleukinAlso: Proleukin, IL-2Subcutaneous injection equaling 15 x 10^6 IU daily dose. Administration based on individual results after 16 weeks and randomization. | Drug | A, B |
Primary outcome
Virologic: A. Plasma viral load B. Tissue viral load (CNS, lymphoid tissues, genital tract) C. HIV DNA (proviral) levels in circulating mononuclear cells D. Phenotypic and genotypic antiretroviral drug resistance
Time frame: Throughout study
Immunologic: A. Evaluation of CD4, CD8, CD45RA, CD45RO phenotypes and defined activation markers B. Evaluation of the diversity and persistence of the T cell repertoire (CD4+, CD8+) in the circulation and lymphoid tissues
Time frame: Throughout study
Immunologic: C. Functional CD4+ cellular assays (class II MHC tetramers) D. Thymic regeneration as studied by the exclusion circle assay E. Evolution of Western blot banding patterns F. Evolution of anti-HIV neutralizing antibody levels
Time frame: Throughout study
Clinical: A. Minor opportunistic infections or AIDS-defining conditions B. Death C. Clinical or laboratory adverse events D. Evaluation of adherence to therapy E. Evaluation of lipodystrophy
Time frame: Throughout study
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 6 Sep 2013.
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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.
Rafick-Pierre Sekaly principal investigator
Brian Conway principal investigator
4 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, Ritonavir and Abacavir sulfate in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 4 sites in Canada.
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 5 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 6 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. 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.
What does the primary outcome measure?
Virologic: A. Plasma viral load B. Tissue viral load (CNS, lymphoid tissues, genital tract) C. HIV DNA (proviral) levels in circulating mononuclear cells D. Phenotypic and genotypic antiretroviral drug resistance (time frame: Throughout study). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 6 Sep 2013.