HIV InfectionsPhase 1/2NCT00411996
The Pharmacokinetics and Safety of IDV/r With NRTIs in HIV/TB Co-infected Patients Receiving Rifampicin
A Phase 1/2 study testing indinavir/ritonavir in people with HIV Infections and Tuberculosis, run by The HIV Netherlands Australia Thailand Research Collaboration at 1 site in Thailand.
Trial summary
We believe that there is a strong rationale for the study of IDV/r 600/100 bid as a boosted-PI combination that, in the presence of RMP, is able to produce a satisfactory PK profile associated with adequate antiretroviral potency, tolerability and efficacy. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- HIV Infections, Tuberculosis
- What is being tested?
- indinavir/ritonavir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteThailand
- Study dates
- Dec 2006to Dec 2009
- Phase
- Phase 1/2
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Confirmed HIV positive after voluntary counselling and testing
- Aged between 18 and 60 years of age
- Antiretroviral treatment naive
- CD4+ cell count of <200 cells/mm3 at the time of TB diagnosis
- ALT <5 times ULN
- Serum creatinine <1.4 mg/dl
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- Haemoglobin >8 mg/L
- TB diagnosis; either probable (clinical symptoms plus chest x-ray and response to anti-TB medication) or definitive( sputum AFB culture confirmed) and receiving or planning to receive rifampicin-containing anti-TB therapy for at least a 2 week period before the initiation of ART
- No other active OI (CDC class C event)
- Able to provide written informed consent
Who cannot join
- Current use of steroids and other immunosuppressive agents
- Current use of any prohibited medications related to compliance and drug pharmacokinetics
- Patients with current alcohol or illicit substance use that in the opinion of the site Principal Investigator would conflict with any aspect of the conduct of the trial.
- Previous exposure to nevirapine monotherapy
- Unlikely to be able to remain in follow-up for the protocol defined period
- Patients with proven or suspected acute hepatitis. Patients with chronic viral hepatitis are eligible provided ALT, AST < 5 x ULN.
- Karnofsky performance score <30%
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Pharmacokinetics and Safety of Ritonavir-boosted Indinavir 600/100mg Bid Combined With NRTIs in ARV naïve HIV/TB Co-infected Patients Receiving Rifampicin Containing Anti-tuberculosis Therapy
We believe that there is a strong rationale for the study of IDV/r 600/100 bid as a boosted-PI combination that, in the presence of RMP, is able to produce a satisfactory PK profile associated with adequate antiretroviral potency, tolerability and efficacy.
Read the detailed description
The fixed-dose combination of d4T+3TC+NVP (GPOvir) has been widely used in Thailand since June 2002. The prevalence of NNRTI resistance has increased since 2005. Efavirenz-based antiretroviral therapy (ART) is preferred in patients with TB/HIV receiving rifampin-containing TB regimens. However, efavirenz cannot be used in the context of NNRTI failure, intolerance or toxicity. The optimal ART in populations receiving rifampicin remains unknown. Rifabutin, which is recommended in combination with a boosted protease inhibitor (PI/r) is expensive and not available in Thailand and other developing countries. Ritonavir-boosted indinavir (IDV/r) is potent and the cheapest boosted PI available in Thailand. If IDV/r in combination with rifampin demonstrates suitable pharmacokinetics and is well tolerated, this regimen might prove useful and could be widely implemented. However, high rates of gastrointestinal and renal toxicity have been demonstrated in Thai patients receiving standard doses of IDV/r 800/100 BID. We believe that there is a strong rationale to study if IDV/r 600/100 BID in combination with rifampin is able to produce a satisfactory pharmacokinetic profile, with antiretroviral potency, tolerability and efficacy.
- Conditions
- HIV Infections, Tuberculosis
- Being tested
- indinavir/ritonavir
- Keywords
- indinavir/ritonavir, HIV/TB, rifampicin, PK and efficacy of IDV/RTV 600/100 mg BID with rifampicin, Treatment Naive
- Medical subject headings
- HIV Infections, Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
indinavir/ritonavirDrug
IDV/r 600/100 mg BID + rifampicin OD for at least 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | IDV/r 600/100 mg + rifampicin Receives: Drug: indinavir/ritonavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
pharmacokinetics of ritonavir-boosted indinavir 600/100mg bid in combination with rifampicin-containing anti-TB therapy.
Measured: 2 weeks
Secondary outcomes (3)
safety of ritonavir-boosted indinavir 600/100mg bid in combination with rifampicin-containing anti-TB therapy
Measured: 48 weeks
efficacy of ritonavir-boosted indinavir 600/100mg bid in combination with rifampicin-containing anti-TB therapy
Measured: 48 weeks
the prevalence of immune recovery syndrome of TB and other HIV-related conditions after ritonavir-boosted indinavir 600/100mg bid
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2006 (estimated)
- Study startDec 2006
- Primary completionOct 2008
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- The HIV Netherlands Australia Thailand Research Collaboration
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kiat Ruxrungtham, MD, Principal investigator, HIV-NAT, Thai Red Cross AIDS Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00411996
- Sponsor's protocol ID
- HIV-NAT 044
- Status last verified
- Jul 2020
- First submitted
- 14 Dec 2006
- Last updated
- 17 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Avihingsanon A, van der Lugt J, Singphore U, Gorowara M, Boyd M, Ananworanich J, Phanuphak P, Burger D, Ruxrungtham K. Pharmacokinetics and 48 week efficacy of adjusted dose indinavir/ritonavir in rifampicin-treated HIV/tuberculosis-coinfected patients: a pilot study. AIDS Res Hum Retroviruses. 2012 Oct;28(10):1170-6. doi: 10.1089/AID.2011.0247. Epub 2012 Mar 6.
PubMed 22250979
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Pharmacokinetics and Safety of Ritonavir-boosted Indinavir 600/100mg Bid Combined With NRTIs in ARV naïve HIV/TB Co-infected Patients Receiving Rifampicin Containing Anti-tuberculosis Therapy
- ClinicalTrials.gov ID
- NCT00411996
- Acronym / sponsor ID
- HIV-NAT 044
- Conditions
- HIV Infections, Tuberculosis
- Keywords
- indinavir/ritonavir, HIV/TB, rifampicin, PK and efficacy of IDV/RTV 600/100 mg BID with rifampicin, Treatment Naive
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- The HIV Netherlands Australia Thailand Research CollaborationUniversity, hospital or other
- Study start
- Dec 2006
- Primary completion
- Oct 2008 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 15 Dec 2006 (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.
We believe that there is a strong rationale for the study of IDV/r 600/100 bid as a boosted-PI combination that, in the presence of RMP, is able to produce a satisfactory PK profile associated with adequate antiretroviral potency, tolerability and efficacy.
Detailed description
The fixed-dose combination of d4T+3TC+NVP (GPOvir) has been widely used in Thailand since June 2002. The prevalence of NNRTI resistance has increased since 2005. Efavirenz-based antiretroviral therapy (ART) is preferred in patients with TB/HIV receiving rifampin-containing TB regimens. However, efavirenz cannot be used in the context of NNRTI failure, intolerance or toxicity. The optimal ART in populations receiving rifampicin remains unknown. Rifabutin, which is recommended in combination with a boosted protease inhibitor (PI/r) is expensive and not available in Thailand and other developing countries. Ritonavir-boosted indinavir (IDV/r) is potent and the cheapest boosted PI available in Thailand. If IDV/r in combination with rifampin demonstrates suitable pharmacokinetics and is well tolerated, this regimen might prove useful and could be widely implemented. However, high rates of gastrointestinal and renal toxicity have been demonstrated in Thai patients receiving standard doses of IDV/r 800/100 BID. We believe that there is a strong rationale to study if IDV/r 600/100 BID in combination with rifampin is able to produce a satisfactory pharmacokinetic profile, with antiretroviral potency, tolerability and efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Drug: indinavir/ritonavirIDV/r 600/100 mg + rifampicin |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Confirmed HIV positive after voluntary counselling and testing
- Aged between 18 and 60 years of age
- Antiretroviral treatment naive
- CD4+ cell count of <200 cells/mm3 at the time of TB diagnosis
- ALT <5 times ULN
Key exclusion criteria (7 listed)
- Current use of steroids and other immunosuppressive agents
- Current use of any prohibited medications related to compliance and drug pharmacokinetics
- Patients with current alcohol or illicit substance use that in the opinion of the site Principal Investigator would conflict with any aspect of the conduct of the trial.
- Previous exposure to nevirapine monotherapy
- Unlikely to be able to remain in follow-up for the protocol defined period
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/ritonavirIDV/r 600/100 mg BID + rifampicin OD for at least 2 weeks | Drug | 1 |
Primary outcome
pharmacokinetics of ritonavir-boosted indinavir 600/100mg bid in combination with rifampicin-containing anti-TB therapy.
Time frame: 2 weeks
3 secondary outcomes
safety of ritonavir-boosted indinavir 600/100mg bid in combination with rifampicin-containing anti-TB therapy
Time frame: 48 weeks
efficacy of ritonavir-boosted indinavir 600/100mg bid in combination with rifampicin-containing anti-TB therapy
Time frame: 48 weeks
the prevalence of immune recovery syndrome of TB and other HIV-related conditions after ritonavir-boosted indinavir 600/100mg bid
Time frame: 48 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 17 Jul 2020.
- Derived from this study: PubMed 22250979Avihingsanon A, van der Lugt J, Singphore U, Gorowara M, Boyd M, Ananworanich J, Phanuphak P, Burger D, Ruxrungtham K. Pharmacokinetics and 48 week efficacy of adjusted dose indinavir/ritonavir in rifampicin-treated HIV/tuberculosis-coinfected patients: a pilot study. AIDS Res Hum Retroviruses. 2012 Oct;28(10):1170-6. doi: 10.1089/AID.2011.0247. Epub 2012 Mar 6.
- The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)Link provided by the sponsor.
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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.
Kiat Ruxrungtham, MD principal investigator
HIV-NAT, Thai Red Cross AIDS Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing indinavir/ritonavir in people with HIV Infections and Tuberculosis, run by The HIV Netherlands Australia Thailand Research Collaboration at 1 site in Thailand.
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 7 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 17 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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.
What does the primary outcome measure?
pharmacokinetics of ritonavir-boosted indinavir 600/100mg bid in combination with rifampicin-containing anti-TB therapy. (time frame: 2 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 NCT00411996, which also lists 1 linked publication.
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 17 Jul 2020.