HIV InfectionMAINTAINNCT00798772
Micronutrients and Antioxidants in HIV Infection
A study testing Micronutrients and antioxidants and Multivitamins and minerals in people with HIV Infection, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
Infection with human immunodeficiency virus (HIV) causes decline in immunity or the ability to fight infection and progresses to acquired immunodeficiency disease (AIDS). Anti-HIV drug treatment has improved the prognosis of persons with HIV infection, but is expensive and potentially toxic. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infection
- What is being tested?
- Micronutrients and antioxidants and Multivitamins and minerals
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 171 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2009to 6 Dec 2017
- Phase
- Interventional
- 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
- be an asymptomatic HIV infected adult
- at least 18 years of age
- have CD4+ cells between 375 and 750 cells/mm3
- have received no ART (excluding less than seven days and perinatal transmission prophylaxis)
- if a woman of child bearing potential, have a negative pregnancy test within two weeks prior to randomization and agree to practice barrier method of birth control during the study
- be willing and able to sign informed consent and to comply with the study protocol
Who cannot join
- have HIV-2 infection alone
- have known allergy or intolerance to any study medication ingredient
- be pregnant
- have active treatment for an acute opportunistic infection or malignancy
- have ALT greater than 3 x normal range
- have known cirrhosis of the liver
Show all 9Show fewer
- have serum creatinine less than 133 umol/L
- abuse alcohol and recreational drugs
- be taking micronutrient (except vitamin D*) or natural health product supplements within 30 days of randomization *Maximum 2000 IU daily (Health Canada Guidelines).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Control Clinical Trial Of Micronutrient & Antioxidant Supplementation in Persons With Untreated HIV Infection
Infection with human immunodeficiency virus (HIV) causes decline in immunity or the ability to fight infection and progresses to acquired immunodeficiency disease (AIDS). Anti-HIV drug treatment has improved the prognosis of persons with HIV infection, but is expensive and potentially toxic. Low micronutrient levels occur in the blood even in early stages of HIV infection and increase risk of a poorer prognosis, but the role of micronutrient and antioxidant supplements in medical management of HIV/AIDS is not well defined. The proposed clinical trial aims to assess if supplementation of untreated HIV-infected adults with a micronutrient and antioxidant preparation can delay decline in immunity or disease progression or start of anti-HIV drug treatment compared with supplementation with standard multivitamins. If the findings are positive, the study has implications for health and health care savings.
Read the detailed description
Background: Antiretroviral therapy (ART) has improved the prognosis of persons with human immunodeficiency virus (HIV) infection, but is expensive and potentially toxic. Micronutrient deficiencies occur even in early stages of HIV infection and increase risk of morbidity, disease progression to acquired immunodeficiency syndrome (AIDS) and mortality, but the role of micronutrient antioxidant supplements in medical management of HIV/AIDS is not clear.
Objective: To determine if supplementation of untreated asymptomatic HIV-infected persons with a broad-spectrum micronutrient and antioxidant preparation will reduce the rate of decline of CD4 T lymphocyte count, or delay emergence of documented CDC-defined AIDS-defining illness, or start of ART compared to 100% recommended daily allowance (RDA) multivitamins and minerals, and is safe.
Study design: A prospective, randomized, controlled, double blind clinical trial of supplementation of 218 untreated asymptomatic HIV-infected adults with a micronutrient and antioxidant preparation or identical appearing RDA multivitamins and minerals for two years, with quarterly follow up in clinic for assessment of time from baseline to CD4 count <350 mm3, or emergence of documented CDC-defined AIDS-defining illness, or start of ART.
Participants and sample size: 218 participants from clinics in Ontario and other participating centres of the CIHR Canadian HIV Trials Network (CTN).
Study duration: approximately five years, allowing for approximately three years for participant accrual and two years follow-up.
Eligibility criteria: The main eligibility criteria are:
- Asymptomatic HIV-infected adults at least 18 years of age
- CD4+ cells ≥375 and ≤750 cells/mm3
- No previous ART (excluding less than seven days and perinatal transmission prophylaxis) Study intervention: Oral supplementation with a broad spectrum micronutrient and antioxidant preparation (n=109) or identical appearing RDA multivitamins and minerals (n=109).
Primary outcome: Time from baseline to CD4+ cell count <350 cells/mm3 (confirmed by two measures at least one week apart), or emergence of documented CDC-defined AIDS-defining illness, or start of ART
Secondary outcomes:
- Non-AIDS related adverse events
- Tolerance of and adherence to study medication
- Time from baseline to CD4+ cell count <350 cells/mm3 (confirmed by two measures at least one week apart)
- Time from baseline to emergence of documented CDC-defined AIDS-defining illness
- Time from baseline to start of ART
- Serial quarterly lymphocyte measures: absolute lymphocyte count (ALC), CD4+, CD8+, and CD3+ cell counts, CD4%, CD8%, CD4:CD8
- Serial quarterly HIV RNA plasma viral load
- Serum chemistries: Glucose, BUN, creatinine, total protein, C-reactive protein, albumin, alkaline phosphatase, ALT, AST, total bilirubin
- Serum micronutrient levels: Carotene (quarterly) and vitamin B12 (quarterly), folate (six monthly) and vitamin D (25-OHD, six monthly)
- Quality of Life measures: MOS HIV, EuroQol, and Health Utilities Index (HUI) Statistical analysis: Analysis of the primary outcome by intention-to-treat will compare time from baseline to primary outcome. Interim analyses are planned once 100 participants are followed for one year.
- Conditions
- HIV Infection
- Being tested
- Micronutrients and antioxidants, Multivitamins and minerals
- Keywords
- HIV infection, Micronutrients, Antioxidants
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micronutrients and antioxidantsDietary supplement
Also called K-PAX Ultra
8 capsules twice daily for two years
Multivitamins and mineralsDietary supplement
Also called Centrum-like multivitamins and minerals
8 capsules twice daily for two years
| Study group | Role | What they receive |
|---|---|---|
| A: Broad spectrum micronutrients | Experimental | The experimental treatment medications (micronutrients and antioxidants) will be taken as one packet (8 capsules) twice a day with meals. Because of the presence of calcium, iron and zinc in the study medication, any other medication must be taken at least two hours before or after taking it. Participants may initiate the intervention at half dose (one packet of 8 capsules once a day) and increase to full dose after one week.
The intervention will last for two years. Receives: Dietary Supplement: Micronutrients and antioxidants |
| B: Identical appearing multivitamins | Active comparator | The active comparator/control medications (identical appearing RDA multivitamins and minerals) will be taken as one packet (8 capsules) twice a day with meals. Because of the presence of calcium, iron and zinc in the study medication, any other medication must be taken at least two hours before or after taking it. Participants may initiate the intervention at half dose (one packet of 8 capsules once a day) and increase to full dose after one week.
The intervention will last for two years. Receives: Dietary Supplement: Multivitamins and minerals |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from baseline to CD4+ cell count <350 cells/mm3 (confirmed by two measures at least one week apart), or emergence of documented CDC-defined AIDS-defining illness, or start of ART
Measured: Quarterly
Secondary outcomes (10)
Non-AIDS related adverse events
Measured: Quarterly
Tolerance of and adherence to study medication
Measured: Quarterly
Time from baseline to CD4+ cell count <350 cells/mm3 (confirmed by two measures at least one week apart)
Measured: Quarterly
Time from baseline to emergence of documented CDC-defined AIDS-defining illness
Measured: Quarterly
Time from baseline to start of ART
Measured: Quarterly
Serial quarterly lymphocyte measures (ALC, CD4+, CD8+, and CD3+ cell counts, CD4%, CD8%, CD4:CD8)
Measured: Quarterly
Serial quarterly HIV RNA plasma viral load
Measured: Quarterly
Serum chemistries: Glucose, BUN, creatinine, total protein, albumin, alkaline phosphatase, ALT, AST, total bilirubin,
Measured: Quarterly
Serum micronutrient levels: carotene (quarterly), vitamin B12 (quarterly), folate (six monthly) and vitamin D (25-OHD six monthly)
Measured: Quarterly or as specified
Quality of Life measures
Measured: Quarterly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2008 (estimated)
- Study startJan 2009
- Primary completionMay 2014
- Study completion6 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Treatment group (Group A): Will receive micronutrients and antioxidants. Control group (Group B): Will receive identical appearing RDA multivitamins and minerals
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 171 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- CIHR Canadian HIV Trials Network, Ontario HIV Treatment Network
- Responsible party
- Sponsor
- Investigators
- William Cameron, MD, FRCPC, Principal investigator, University of Ottawa at The Ottawa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00798772
- Sponsor's protocol ID
- CTN 238
- Acronym
- MAINTAIN
- Status last verified
- Apr 2018
- First submitted
- 25 Nov 2008
- Last updated
- 17 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Austin J, Singhal N, Voigt R, Smaill F, Gill MJ, Walmsley S, Salit I, Gilmour J, Schlech WF 3rd, Choudhri S, Rachlis A, Cohen J, Trottier S, Toma E, Phillips P, Ford PM, Woods R, Singer J, Zarowny DP, Cameron DW; CTN 091/CRIT Cartenoids Study Group. A community randomized controlled clinical trial of mixed carotenoids and micronutrient supplementation of patients with acquired immunodeficiency syndrome. Eur J Clin Nutr. 2006 Nov;60(11):1266-76. doi: 10.1038/sj.ejcn.1602447. Epub 2006 May 24.
PubMed 16721396Kaiser JD, Campa AM, Ondercin JP, Leoung GS, Pless RF, Baum MK. Micronutrient supplementation increases CD4 count in HIV-infected individuals on highly active antiretroviral therapy: a prospective, double-blinded, placebo-controlled trial. J Acquir Immune Defic Syndr. 2006 Aug 15;42(5):523-8. doi: 10.1097/01.qai.0000230529.25083.42.
PubMed 16868496Wobeser WL, McBane JE, Balfour L, Conway B, Gill MJ, Huff H, Kilby DLP, Fergusson DA, Mallick R, Mills EJ, Muldoon KA, Rachlis A, Ralph ED, Rosenes R, Singer J, Singhal N, Tan D, Tremblay N, Vo D, Walmsley SL, Cameron DW; MAINTAIN Study Group. A randomized control trial of high-dose micronutrient-antioxidant supplementation in healthy persons with untreated HIV infection. PLoS One. 2022 Jul 14;17(7):e0270590. doi: 10.1371/journal.pone.0270590. eCollection 2022.
PubMed 35834528Balfour L, Spaans JN, Fergusson D, Huff H, Mills EJ, la Porte CJ, Walmsley S, Singhal N, Rosenes R, Tremblay N, Gill MJ, Loemba H, Conway B, Rachlis A, Ralph E, Loutfy M, Mallick R, Moorhouse R, William Cameron D. Micronutrient deficiency and treatment adherence in a randomized controlled trial of micronutrient supplementation in ART-naive persons with HIV. PLoS One. 2014 Jan 21;9(1):e85607. doi: 10.1371/journal.pone.0085607. eCollection 2014.
PubMed 24465617
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Control Clinical Trial Of Micronutrient & Antioxidant Supplementation in Persons With Untreated HIV Infection
- ClinicalTrials.gov ID
- NCT00798772
- Acronym / sponsor ID
- MAINTAIN / CTN 238
- Conditions
- HIV Infection
- Keywords
- HIV infection, Micronutrients, Antioxidants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- CIHR Canadian HIV Trials Network, Ontario HIV Treatment Network
- Study start
- Jan 2009
- Primary completion
- May 2014 (actual)
- Study completion
- 6 Dec 2017 (actual)
- First posted
- 26 Nov 2008 (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.
Infection with human immunodeficiency virus (HIV) causes decline in immunity or the ability to fight infection and progresses to acquired immunodeficiency disease (AIDS). Anti-HIV drug treatment has improved the prognosis of persons with HIV infection, but is expensive and potentially toxic. Low micronutrient levels occur in the blood even in early stages of HIV infection and increase risk of a poorer prognosis, but the role of micronutrient and antioxidant supplements in medical management of HIV/AIDS is not well defined. The proposed clinical trial aims to assess if supplementation of untreated HIV-infected adults with a micronutrient and antioxidant preparation can delay decline in immunity or disease progression or start of anti-HIV drug treatment compared with supplementation with standard multivitamins. If the findings are positive, the study has implications for health and health care savings.
Detailed description
Background: Antiretroviral therapy (ART) has improved the prognosis of persons with human immunodeficiency virus (HIV) infection, but is expensive and potentially toxic. Micronutrient deficiencies occur even in early stages of HIV infection and increase risk of morbidity, disease progression to acquired immunodeficiency syndrome (AIDS) and mortality, but the role of micronutrient antioxidant supplements in medical management of HIV/AIDS is not clear.
Objective: To determine if supplementation of untreated asymptomatic HIV-infected persons with a broad-spectrum micronutrient and antioxidant preparation will reduce the rate of decline of CD4 T lymphocyte count, or delay emergence of documented CDC-defined AIDS-defining illness, or start of ART compared to 100% recommended daily allowance (RDA) multivitamins and minerals, and is safe.
Study design: A prospective, randomized, controlled, double blind clinical trial of supplementation of 218 untreated asymptomatic HIV-infected adults with a micronutrient and antioxidant preparation or identical appearing RDA multivitamins and minerals for two years, with quarterly follow up in clinic for assessment of time from baseline to CD4 count <350 mm3, or emergence of documented CDC-defined AIDS-defining illness, or start of ART.
Participants and sample size: 218 participants from clinics in Ontario and other participating centres of the CIHR Canadian HIV Trials Network (CTN).
Study duration: approximately five years, allowing for approximately three years for participant accrual and two years follow-up.
Eligibility criteria: The main eligibility criteria are:
- Asymptomatic HIV-infected adults at least 18 years of age
- CD4+ cells ≥375 and ≤750 cells/mm3
- No previous ART (excluding less than seven days and perinatal transmission prophylaxis) Study intervention: Oral supplementation with a broad spectrum micronutrient and antioxidant preparation (n=109) or identical appearing RDA multivitamins and minerals (n=109).
Primary outcome: Time from baseline to CD4+ cell count <350 cells/mm3 (confirmed by two measures at least one week apart), or emergence of documented CDC-defined AIDS-defining illness, or start of ART
Secondary outcomes:
- Non-AIDS related adverse events
- Tolerance of and adherence to study medication
- Time from baseline to CD4+ cell count <350 cells/mm3 (confirmed by two measures at least one week apart)
- Time from baseline to emergence of documented CDC-defined AIDS-defining illness
- Time from baseline to start of ART
- Serial quarterly lymphocyte measures: absolute lymphocyte count (ALC), CD4+, CD8+, and CD3+ cell counts, CD4%, CD8%, CD4:CD8
- Serial quarterly HIV RNA plasma viral load
- Serum chemistries: Glucose, BUN, creatinine, total protein, C-reactive protein, albumin, alkaline phosphatase, ALT, AST, total bilirubin
- Serum micronutrient levels: Carotene (quarterly) and vitamin B12 (quarterly), folate (six monthly) and vitamin D (25-OHD, six monthly)
- Quality of Life measures: MOS HIV, EuroQol, and Health Utilities Index (HUI) Statistical analysis: Analysis of the primary outcome by intention-to-treat will compare time from baseline to primary outcome. Interim analyses are planned once 100 participants are followed for one year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Treatment group (Group A): Will receive micronutrients and antioxidants. Control group (Group B): Will receive identical appearing RDA multivitamins and minerals
| Arm | Type | Receives |
|---|---|---|
| A: Broad spectrum micronutrients | Experimental | Dietary Supplement: Micronutrients and antioxidantsThe experimental treatment medications (micronutrients and antioxidants) will be taken as one packet (8 capsules) twice a day with meals. Because of the presence of calcium, iron and zinc in the study medication, any other medication must be taken at least two hours before or after taking it. Participants may initiate the intervention at half dose (one packet of 8 capsules once a day) and increase to full dose after one week. The intervention will last for two years. |
| B: Identical appearing multivitamins | Active comparator | Dietary Supplement: Multivitamins and mineralsThe active comparator/control medications (identical appearing RDA multivitamins and minerals) will be taken as one packet (8 capsules) twice a day with meals. Because of the presence of calcium, iron and zinc in the study medication, any other medication must be taken at least two hours before or after taking it. Participants may initiate the intervention at half dose (one packet of 8 capsules once a day) and increase to full dose after one week. The intervention will last for two years. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- be an asymptomatic HIV infected adult
- at least 18 years of age
- have CD4+ cells between 375 and 750 cells/mm3
- have received no ART (excluding less than seven days and perinatal transmission prophylaxis)
- if a woman of child bearing potential, have a negative pregnancy test within two weeks prior to randomization and agree to practice barrier method of birth control during the study
Key exclusion criteria (9 listed)
- have HIV-2 infection alone
- have known allergy or intolerance to any study medication ingredient
- be pregnant
- have active treatment for an acute opportunistic infection or malignancy
- have ALT greater than 3 x normal range
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 |
|---|---|---|
| Micronutrients and antioxidantsAlso: K-PAX Ultra8 capsules twice daily for two years | Dietary supplement | A: Broad spectrum micronutrients |
| Multivitamins and mineralsAlso: Centrum-like multivitamins and minerals8 capsules twice daily for two years | Dietary supplement | B: Identical appearing multivitamins |
Primary outcome
Time from baseline to CD4+ cell count <350 cells/mm3 (confirmed by two measures at least one week apart), or emergence of documented CDC-defined AIDS-defining illness, or start of ART
Time frame: Quarterly
10 secondary outcomes
Non-AIDS related adverse events
Time frame: Quarterly
Tolerance of and adherence to study medication
Time frame: Quarterly
Time from baseline to CD4+ cell count <350 cells/mm3 (confirmed by two measures at least one week apart)
Time frame: Quarterly
Time from baseline to emergence of documented CDC-defined AIDS-defining illness
Time frame: Quarterly
Time from baseline to start of ART
Time frame: Quarterly
Serial quarterly lymphocyte measures (ALC, CD4+, CD8+, and CD3+ cell counts, CD4%, CD8%, CD4:CD8)
Time frame: Quarterly
Serial quarterly HIV RNA plasma viral load
Time frame: Quarterly
Serum chemistries: Glucose, BUN, creatinine, total protein, albumin, alkaline phosphatase, ALT, AST, total bilirubin,
Time frame: Quarterly
Serum micronutrient levels: carotene (quarterly), vitamin B12 (quarterly), folate (six monthly) and vitamin D (25-OHD six monthly)
Time frame: Quarterly or as specified
Quality of Life measures
Time frame: Quarterly
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 Apr 2018.
- Background: PubMed 16721396Austin J, Singhal N, Voigt R, Smaill F, Gill MJ, Walmsley S, Salit I, Gilmour J, Schlech WF 3rd, Choudhri S, Rachlis A, Cohen J, Trottier S, Toma E, Phillips P, Ford PM, Woods R, Singer J, Zarowny DP, Cameron DW; CTN 091/CRIT Cartenoids Study Group. A community randomized controlled clinical trial of mixed carotenoids and micronutrient supplementation of patients with acquired immunodeficiency syndrome. Eur J Clin Nutr. 2006 Nov;60(11):1266-76. doi: 10.1038/sj.ejcn.1602447. Epub 2006 May 24.
- Background: PubMed 16868496Kaiser JD, Campa AM, Ondercin JP, Leoung GS, Pless RF, Baum MK. Micronutrient supplementation increases CD4 count in HIV-infected individuals on highly active antiretroviral therapy: a prospective, double-blinded, placebo-controlled trial. J Acquir Immune Defic Syndr. 2006 Aug 15;42(5):523-8. doi: 10.1097/01.qai.0000230529.25083.42.
- Derived from this study: PubMed 35834528Wobeser WL, McBane JE, Balfour L, Conway B, Gill MJ, Huff H, Kilby DLP, Fergusson DA, Mallick R, Mills EJ, Muldoon KA, Rachlis A, Ralph ED, Rosenes R, Singer J, Singhal N, Tan D, Tremblay N, Vo D, Walmsley SL, Cameron DW; MAINTAIN Study Group. A randomized control trial of high-dose micronutrient-antioxidant supplementation in healthy persons with untreated HIV infection. PLoS One. 2022 Jul 14;17(7):e0270590. doi: 10.1371/journal.pone.0270590. eCollection 2022.
- Derived from this study: PubMed 24465617Balfour L, Spaans JN, Fergusson D, Huff H, Mills EJ, la Porte CJ, Walmsley S, Singhal N, Rosenes R, Tremblay N, Gill MJ, Loemba H, Conway B, Rachlis A, Ralph E, Loutfy M, Mallick R, Moorhouse R, William Cameron D. Micronutrient deficiency and treatment adherence in a randomized controlled trial of micronutrient supplementation in ART-naive persons with HIV. PLoS One. 2014 Jan 21;9(1):e85607. doi: 10.1371/journal.pone.0085607. eCollection 2014.
- Individual participant dataSharing planned: Undecided
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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.
William Cameron, MD, FRCPC principal investigator
University of Ottawa at The Ottawa Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Micronutrients and antioxidants and Multivitamins and minerals in people with HIV Infection, run by Ottawa Hospital Research Institute at 1 site 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 6 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 17 Apr 2018. 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 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.
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?
Time from baseline to CD4+ cell count <350 cells/mm3 (confirmed by two measures at least one week apart), or emergence of documented CDC-defined AIDS-defining illness, or start of ART (time frame: Quarterly). 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 NCT00798772, which also lists 4 linked publications.
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 Apr 2018.