HIVPhase 4NCT01694017
Economic, Clinical and Quality of Life Assessment in Patients on Antiretroviral Therapy
A Phase 4 study testing Tenofovir and Zidovudine in people with HIV, run by Tufts University at 1 site in India.
Trial summary
The purpose of this study is to compare clinical, economical and quality of life (QOL) outcomes in patients living with HIV on zidovudine/stavudine regimen and tenofovir regimen. This study will be an unblinded randomized trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV
- What is being tested?
- Tenofovir and Zidovudine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteIndia
- Study dates
- Nov 2012to Aug 2014
- Phase
- Phase 4
- 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
- All treatment naïve patients above 18 years confirmed with the diagnosis of HIV
- Eligible for initiation of cART based on the National Aids Control Organization of India
- Consenting for participation and follow-up for one year.
Who cannot join
- All patients requiring hospitalization at the time of initiation of treatment
- Patients with opportunistic infections including tuberculosis
- Patients with co-morbidities like diabetes or neurological impairments
- Pregnant and breast feeding women and children less than 18 years will be excluded
- All patients living outside the catchment area of CMC and not willing for regular follow-up will be excluded
- Patients with a creatinine clearance less than 50 mL/min will be excluded.
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- Patients receiving other co-medications with possible interaction with tenofovir, like antifungal (voriconazole), ergot derivatives (dihydroergotamine, ergonovine, ergotamine, and methylergonovine), benzodiazepines (midazolam, triazolam), calcium channel blocker (bepridil), GI motility agent (cisapride), neuroleptic (pimozide) and St.John's wort will be excluded.
- Patients with hemoglobin less than 8 gm/dl
- Patients started on tenofovir regimen by the treating physician at the time of enrollment will be excluded
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Economic Evaluation of Treatment of HIV With Zidovudine/Stavudine and Tenofovir Regimen: A Cost Effectiveness Study
The purpose of this study is to compare clinical, economical and quality of life (QOL) outcomes in patients living with HIV on zidovudine/stavudine regimen and tenofovir regimen. This study will be an unblinded randomized trial. The first step will be empirical data collection for one year for calculating the incremental cost effectiveness ratio (ICER). The second step will be to perform a simulation model for calculating long term ICER.
Read the detailed description
The drug regimen for treatment of HIV at the free ART centers in India includes stavudine/zidovudine and lamivudine with nevirapine. Approximately 20-30% of the patients on this regimen experience drug toxicity within the first six months of treatment.
The tenofovir based regimen is one of the least toxic regimens with less than 5% of patients experiencing toxicity. Tenofovir based regimen is not considered as the first choice for ART in the Indian governmental program, because it is more expensive than the other drug regimens, in spite of better clinical outcomes in resource limited settings. The cost of treatment with stavudine/zidovudine is presumed to be less expensive and is the preferred first line treatment, but we believe that although the direct cost to the government is less, patients on zidovudine/stavudine regimen have to spend more money for additional hospital visits and admissions, laboratory investigations and other medications due to ART induced toxicity.
There are no published data including economic, clinical and quality of life outcomes to compare the two regimens from India. Hence, this unblinded randomized pragmatic comparative effectiveness study will seek to identify the best treatment for HIV patients based on the incremental cost effectiveness ratio (ICER), quality of life (QOL) and clinical outcomes.
The clinical outcomes include viral suppression, change in the CD4 and proportion of patients with toxicity and opportunistic infections. Direct costs for the treatment will be calculated. The QOL scores will be estimated and compared between the regimens using questionnaires. QOL scores and direct cost will be used as utilities for calculating ICER.
- Conditions
- HIV
- Being tested
- Tenofovir, Zidovudine
- Keywords
- HIV,treatment,cost effectiveness,drug toxicity,QOL,costs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TenofovirDrug
Also called Atripla, Vonavir
tenofovir 300 mg+ emtricitabine 200 mg + efavirenz 600 mg, once daily, for one year
ZidovudineDrug
Also called Lazid-N, Duovir-N, Zidolam-N
zidovudine 300 mg + lamivudine 150 mg + nevirapine 200 mg , once daily, for a year
| Study group | Role | What they receive |
|---|---|---|
| Zidovudine | Active comparator | zidovudine 300 mg + lamivudine 150 mg + nevirapine 200 mg , once daily, for a year Receives: Drug: Zidovudine |
| Tenofovir | Active comparator | tenofovir 300 mg+ emtricitabine 200 mg + efavirenz 600 mg, once daily, for one year Receives: Drug: Tenofovir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Viral suppression
Measured: End of follow-up : end of 12th Month
Change in CD4 levels
Measured: End of Months 6 and 12
Drug related toxicity
Measured: Months : 1,2,3,4,5,6,7,8,9,10,11,12
opportunistic infections
Measured: Months: 1,2,3,4,5,6,7,8,9,10,11,12
Direct costs
Measured: Months: 1,2,3,4,5,6,7,8,9,10,11,12
Quality of life
Measured: Month 1 and end of months 4,8 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2012 (estimated)
- Study startNov 2012
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Collaborators
- Christian Medical College, Vellore, India
- Responsible party
- Principal investigator, Christine A. Wanke, Tufts University
- Investigators
- Christine C Wanke, MD, Study chair, Tufts UniversitySowmyanarayanan V Thuppal, MD, Principal investigator, Tufts University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01694017
- Sponsor's protocol ID
- 10465
- Status last verified
- Nov 2014
- First submitted
- 18 Sep 2012
- Last updated
- 24 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Economic Evaluation of Treatment of HIV With Zidovudine/Stavudine and Tenofovir Regimen: A Cost Effectiveness Study
- ClinicalTrials.gov ID
- NCT01694017
- Acronym / sponsor ID
- 10465
- Conditions
- HIV
- Keywords
- HIV,treatment,cost effectiveness,drug toxicity,QOL,costs
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Collaborators
- Christian Medical College, Vellore, India
- Study start
- Nov 2012
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 26 Sep 2012 (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 clinical, economical and quality of life (QOL) outcomes in patients living with HIV on zidovudine/stavudine regimen and tenofovir regimen. This study will be an unblinded randomized trial. The first step will be empirical data collection for one year for calculating the incremental cost effectiveness ratio (ICER). The second step will be to perform a simulation model for calculating long term ICER.
Detailed description
The drug regimen for treatment of HIV at the free ART centers in India includes stavudine/zidovudine and lamivudine with nevirapine. Approximately 20-30% of the patients on this regimen experience drug toxicity within the first six months of treatment.
The tenofovir based regimen is one of the least toxic regimens with less than 5% of patients experiencing toxicity. Tenofovir based regimen is not considered as the first choice for ART in the Indian governmental program, because it is more expensive than the other drug regimens, in spite of better clinical outcomes in resource limited settings. The cost of treatment with stavudine/zidovudine is presumed to be less expensive and is the preferred first line treatment, but we believe that although the direct cost to the government is less, patients on zidovudine/stavudine regimen have to spend more money for additional hospital visits and admissions, laboratory investigations and other medications due to ART induced toxicity.
There are no published data including economic, clinical and quality of life outcomes to compare the two regimens from India. Hence, this unblinded randomized pragmatic comparative effectiveness study will seek to identify the best treatment for HIV patients based on the incremental cost effectiveness ratio (ICER), quality of life (QOL) and clinical outcomes.
The clinical outcomes include viral suppression, change in the CD4 and proportion of patients with toxicity and opportunistic infections. Direct costs for the treatment will be calculated. The QOL scores will be estimated and compared between the regimens using questionnaires. QOL scores and direct cost will be used as utilities for calculating ICER.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zidovudine | Active comparator | Drug: Zidovudinezidovudine 300 mg + lamivudine 150 mg + nevirapine 200 mg , once daily, for a year |
| Tenofovir | Active comparator | Drug: Tenofovirtenofovir 300 mg+ emtricitabine 200 mg + efavirenz 600 mg, once daily, for one year |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All treatment naïve patients above 18 years confirmed with the diagnosis of HIV
- Eligible for initiation of cART based on the National Aids Control Organization of India
- Consenting for participation and follow-up for one year.
Key exclusion criteria (9 listed)
- All patients requiring hospitalization at the time of initiation of treatment
- Patients with opportunistic infections including tuberculosis
- Patients with co-morbidities like diabetes or neurological impairments
- Pregnant and breast feeding women and children less than 18 years will be excluded
- All patients living outside the catchment area of CMC and not willing for regular follow-up will be excluded
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 |
|---|---|---|
| TenofovirAlso: Atripla, Vonavirtenofovir 300 mg+ emtricitabine 200 mg + efavirenz 600 mg, once daily, for one year | Drug | Tenofovir |
| ZidovudineAlso: Lazid-N, Duovir-N, Zidolam-Nzidovudine 300 mg + lamivudine 150 mg + nevirapine 200 mg , once daily, for a year | Drug | Zidovudine |
Primary outcome
Viral suppression
Time frame: End of follow-up : end of 12th Month
Change in CD4 levels
Time frame: End of Months 6 and 12
Drug related toxicity
Time frame: Months : 1,2,3,4,5,6,7,8,9,10,11,12
opportunistic infections
Time frame: Months: 1,2,3,4,5,6,7,8,9,10,11,12
Direct costs
Time frame: Months: 1,2,3,4,5,6,7,8,9,10,11,12
Quality of life
Time frame: Month 1 and end of months 4,8 and 12
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 Nov 2014.
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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.
Christine C Wanke, MD study chair
Tufts University
Sowmyanarayanan V Thuppal, MD principal investigator
Tufts University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tenofovir and Zidovudine in people with HIV, run by Tufts University at 1 site in India.
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 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 Nov 2014. 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 India. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Viral suppression (time frame: End of follow-up : end of 12th Month). The study lists 6 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 24 Nov 2014.