HIV InfectionsNCT00255840
Evaluation of Two Anti-HIV Treatment Strategies in Resource-Limited South African Communities
A study testing Monitoring by an HIV-trained medical doctor, Monitoring by an HIV-trained primary care nurse and Efavirenz in people with HIV Infections, run by CIPRA SA.
Trial summary
The purpose of this study is to determine the effectiveness of several anti-HIV treatment strategies in resource-poor South African communities. The strategies being studied are using specially trained doctors or nurses to administer HIV care. 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?
- Monitoring by an HIV-trained medical doctor, Monitoring by an HIV-trained primary care nurse and Efavirenz
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 812 participants
- Where
- No sites listed yet
- Study dates
- Jul 2006to Jan 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- HIV-1 infected
- Current severe CDC Category B AIDS-defining illness (with the exception of a single episode of bacterial sepsis or a single episode of zoster), OR history of a severe CDC Category B or C AIDS-defining illness, OR one CD4 count less than 350 cells/mm3 within 6 months prior to study entry
- Antiretroviral naive. A participant who previously received 6 weeks or less of post-exposure prophylaxis or short course therapy for the prevention of mother-to-child transmission are not excluded. More information on this criterion can be found in the protocol.
- Willing to use acceptable forms of contraception
- Parent or guardian willing to provide informed consent, if applicable
Who cannot join
- Current newly diagnosed CDC Category C AIDS-defining opportunistic infection or condition requiring acute therapy at the time of study entry. More information on this criterion can be found in the protocol.
- Therapy with agents with significant systemic myelosuppressive, neurotoxic, pancreatotoxic, hepatotoxic, or cytotoxic potential within 30 days prior to study entry
- Require certain medications
- Current alcohol or substance abuse that, in the opinion of the investigator, may interfere with the study
- Uncontrolled diarrhea (more than 6 stools per day for 7 consecutive days) within 30 days prior to study entry
- Diagnosis of or suspected acute hepatitis within 30 days prior to study entry
Show all 10Show fewer
- Signs or symptoms of bilateral peripheral neuropathy of Grade 2 or greater at screening
- Inability to tolerate oral medication
- Any other clinical condition that, in the opinion of the investigator, may interfere with the study
- In the first trimester of pregnancy
About this study
Official title: "Safeguard the Household" - A Study of HIV Antiretroviral Therapy Treatment Strategies Appropriate for a Resource Poor Country
The purpose of this study is to determine the effectiveness of several anti-HIV treatment strategies in resource-poor South African communities. The strategies being studied are using specially trained doctors or nurses to administer HIV care.
Read the detailed description
The introduction of antiretroviral therapy (ART) for the treatment of HIV has dramatically improved morbidity and mortality for HIV infected people in the developed world. However, research data on the efficacy of ART regimens in developing countries, such as South Africa, are limited. There are an estimated 4.7 million HIV infected individuals in the South African population of about 40 million inhabitants. The greatest social impact may be achieved by treating an entire household affected by HIV to ensure maximum adherence to prescribed ART regimens and to minimize the sharing of antiretroviral drugs. This study will evaluate the effectiveness of ART given by an HIV-trained doctor compared to ART given by an HIV-trained primary health care nurse. Participants failing first-line therapy will receive a second-line regimen based on what medications are available at the clinic, with approval by the clinical safety team. Participants in this study will be recruited from resource-poor communities outside Johannesburg and Cape Town, South Africa.
This study will last 5 years. HIV infected people and other HIV infected members of their household 16 years of age and older will be enrolled. Study participants will receive first-line ART consisting of efavirenz (EFV) once daily, lamivudine (3TC) twice daily, and stavudine (d4T) twice daily. Women of childbearing potential who are unwilling to use acceptable forms of contraception and who have CD4 counts less than 250 cells/mm3 will receive 3TC twice daily; nevirapine (NVP) daily for 2 weeks, then twice daily; and d4T twice daily. Women who are pregnant at baseline, who become pregnant on study treatment, or who are unwilling to use acceptable methods of contraception and have CD4 counts of 250 cells/mm3 or more, or children who were previously exposed to NVP will receive 3TC twice daily, lopinavir/ritonavir (LPV/r) twice daily, and d4T twice daily. Participants will be randomly assigned to one of two arms. Arm 1 will receive ART under the monitoring care of an HIV-trained medical doctor, while Arm 2 will receive ART under the monitoring care of an HIV-trained primary health care nurse with training in HIV diagnosis and treatment. Participants who fail their first-line regimen will receive a second-line regimen but will remain in their treatment arms.
Study visits will occur at study entry; Weeks 2, 4, 8, and 12; and every 12 weeks thereafter. A physical exam, measurement of height and weight, tuberculosis (TB) and hepatitis B infection screening, blood collection, pill counts, and compliance/adherence and resource utilization counseling will occur at most visits. Participants will also be asked to complete quality of life and household cost questionnaires at selected visits. Study visits for participants who fail first-line treatment will occur at treatment failure, between Days 15 and 30, Week 4 post-treatment failure, every 4 weeks until Week 48 post-treatment failure, and every 12 weeks thereafter. A targeted physical exam, measurement of height and weight, TB infection screening, blood collection, pill counts, and compliance/adherence and resource utilization counseling will occur at most visits. Participants will also be asked to complete quality of life and household cost questionnaires at selected visits.
- Conditions
- HIV Infections
- Being tested
- Monitoring by an HIV-trained medical doctor, Monitoring by an HIV-trained primary care nurse, Efavirenz, Lamivudine, Lopinavir/Ritonavir
- Keywords
- Treatment Naive
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monitoring by an HIV-trained medical doctorBehavioural
Participants will receive care from an HIV-trained medical doctor
Monitoring by an HIV-trained primary care nurseBehavioural
Participants will receive care from an HIV-trained primary care nurse
EfavirenzDrug
Also called EFV
600 mg tablet taken orally daily
LamivudineDrug
Also called 3TC
150 mg tablet taken orally daily
Lopinavir/RitonavirDrug
Also called LPV/RTV
400 mg lopinavir/100mg ritonavir tablet taken orally twice daily
NevirapineDrug
Also called NVP
200 mg tablet taken orally for 14 days before taking a 200 mg tablet orally twice daily
StavudineDrug
Also called d4T
Tablet taken orally daily. Dosage depends on weight.
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Study-specified Antiretroviral regimen under care of HIV-trained medical doctor Receives: Behavioral: Monitoring by an HIV-trained medical doctor; Drug: Efavirenz; Drug: Lamivudine; Drug: Lopinavir/Ritonavir; Drug: Nevirapine; Drug: Stavudine |
| B | Active comparator | Study-specified Antiretroviral regimen under care of HIV-trained primary care nurse Receives: Behavioral: Monitoring by an HIV-trained primary care nurse; Drug: Efavirenz; Drug: Lamivudine; Drug: Lopinavir/Ritonavir; Drug: Nevirapine; Drug: Stavudine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative Treatment Failure Rate of Participants on First Line Antiretroviral Therapy Monitored by Primary Health Care Nurses (Investigative Arm)is Not Inferior to the Cumulative Treatment Failure Rate of Participants Monitored by Doctors (Control Arm).
Cumulative treatment failure is a composite endpoint made up of death, virological failure, toxicity failure and protocol-defined loss to follow-up failure.
Measured: 96 weeks
Secondary outcomes (4)
To Compare Subject Adherence to First Line Antiretroviral Treatment as Measured by Pill Count, Between the Two Primary Health Care Monitoring Models.
Measured: Throughout study
Drug Resistance HIV Mutations, Defined by Demonstration of Virologic Failure
Measured: Throughout the study
To Compare the Overall Clinical Safety of Antiretroviral Therapy, as Measured by the Occurrence of Clinical and Laboratory Grade 3 and 4 Adverse Events, Between Primary Health Care Monitoring Arms.
Measured: Throughout study
To Estimate the Total and Incremental Costs, From the Provider and Societal Perspectives, of the Two Approaches (the Primary Health Care Sister and Doctor) to the Provision of Antiretrovirals in Primary Health Care Services in Each Study Site.
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 posted21 Nov 2005 (estimated)
- Study startJul 2006
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 812 participants (actual)
Sponsor and investigators
- Lead sponsor
- CIPRA SA
- Sponsor type
- Research network
- Investigators
- James McIntyre, MBChB, MRCOG, Principal investigator, Perinatal HIV Research Unit, Chris Hani Baragwanath HospitalIan Sanne, MBChB, Principal investigator, University of the Witwatersrand, Thembaletu Clinic, Helen Joseph HospitalRobin Wood, MBChB, FCP (SA), Principal investigator, Department of Medicine, University of Cape Town
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00255840
- Sponsor's protocol ID
- CIPRA-SA Project 1
- Other IDs
- U19AI053217, 3U19AI053217-03S1, 3U19AI053217-04S1, 3U19AI053217-04
- Status last verified
- Jun 2011
- First submitted
- 16 Nov 2005
- Last updated
- 21 Jun 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Hosseinipour MC, Kazembe PN, Sanne IM, van der Horst CM. Challenges in delivering antiretroviral treatment in resource poor countries. AIDS. 2002;16 Suppl 4:S177-87. doi: 10.1097/00002030-200216004-00024. No abstract available.
PubMed 12699015Sanne I, van der Horst C. Research as a path to wide-scale implementation of antiretroviral therapy in Africa. J HIV Ther. 2004 Sep;9(3):65-8.
PubMed 15534564Wools-Kaloustian K, Kimaiyo S. Extending HIV care in resource-limited settings. Curr HIV/AIDS Rep. 2006 Nov;3(4):182-6. doi: 10.1007/s11904-006-0014-1.
PubMed 17032578Brehm JH, Koontz DL, Wallis CL, Shutt KA, Sanne I, Wood R, McIntyre JA, Stevens WS, Sluis-Cremer N, Mellors JW; CIPRA-SA Project 1 Study Team. Frequent emergence of N348I in HIV-1 subtype C reverse transcriptase with failure of initial therapy reduces susceptibility to reverse-transcriptase inhibitors. Clin Infect Dis. 2012 Sep;55(5):737-45. doi: 10.1093/cid/cis501. Epub 2012 May 22.
PubMed 22618567Orrell C, Cohen K, Conradie F, Zeinecker J, Ive P, Sanne I, Wood R. Efavirenz and rifampicin in the South African context: is there a need to dose-increase efavirenz with concurrent rifampicin therapy? Antivir Ther. 2011;16(4):527-34. doi: 10.3851/IMP1780.
PubMed 21685540Sanne I, Orrell C, Fox MP, Conradie F, Ive P, Zeinecker J, Cornell M, Heiberg C, Ingram C, Panchia R, Rassool M, Gonin R, Stevens W, Truter H, Dehlinger M, van der Horst C, McIntyre J, Wood R; CIPRA-SA Study Team. Nurse versus doctor management of HIV-infected patients receiving antiretroviral therapy (CIPRA-SA): a randomised non-inferiority trial. Lancet. 2010 Jul 3;376(9734):33-40. doi: 10.1016/S0140-6736(10)60894-X.
PubMed 20557927
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Safeguard the Household" - A Study of HIV Antiretroviral Therapy Treatment Strategies Appropriate for a Resource Poor Country
- ClinicalTrials.gov ID
- NCT00255840
- Acronym / sponsor ID
- CIPRA-SA Project 1
- Conditions
- HIV Infections
- Keywords
- Treatment Naive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 812 participants (actual)
- Lead sponsor
- CIPRA SAResearch network
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Jul 2006
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 21 Nov 2005 (estimated)
- Results
- Posted 16 Jun 2011
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 determine the effectiveness of several anti-HIV treatment strategies in resource-poor South African communities. The strategies being studied are using specially trained doctors or nurses to administer HIV care.
Detailed description
The introduction of antiretroviral therapy (ART) for the treatment of HIV has dramatically improved morbidity and mortality for HIV infected people in the developed world. However, research data on the efficacy of ART regimens in developing countries, such as South Africa, are limited. There are an estimated 4.7 million HIV infected individuals in the South African population of about 40 million inhabitants. The greatest social impact may be achieved by treating an entire household affected by HIV to ensure maximum adherence to prescribed ART regimens and to minimize the sharing of antiretroviral drugs. This study will evaluate the effectiveness of ART given by an HIV-trained doctor compared to ART given by an HIV-trained primary health care nurse. Participants failing first-line therapy will receive a second-line regimen based on what medications are available at the clinic, with approval by the clinical safety team. Participants in this study will be recruited from resource-poor communities outside Johannesburg and Cape Town, South Africa.
This study will last 5 years. HIV infected people and other HIV infected members of their household 16 years of age and older will be enrolled. Study participants will receive first-line ART consisting of efavirenz (EFV) once daily, lamivudine (3TC) twice daily, and stavudine (d4T) twice daily. Women of childbearing potential who are unwilling to use acceptable forms of contraception and who have CD4 counts less than 250 cells/mm3 will receive 3TC twice daily; nevirapine (NVP) daily for 2 weeks, then twice daily; and d4T twice daily. Women who are pregnant at baseline, who become pregnant on study treatment, or who are unwilling to use acceptable methods of contraception and have CD4 counts of 250 cells/mm3 or more, or children who were previously exposed to NVP will receive 3TC twice daily, lopinavir/ritonavir (LPV/r) twice daily, and d4T twice daily. Participants will be randomly assigned to one of two arms. Arm 1 will receive ART under the monitoring care of an HIV-trained medical doctor, while Arm 2 will receive ART under the monitoring care of an HIV-trained primary health care nurse with training in HIV diagnosis and treatment. Participants who fail their first-line regimen will receive a second-line regimen but will remain in their treatment arms.
Study visits will occur at study entry; Weeks 2, 4, 8, and 12; and every 12 weeks thereafter. A physical exam, measurement of height and weight, tuberculosis (TB) and hepatitis B infection screening, blood collection, pill counts, and compliance/adherence and resource utilization counseling will occur at most visits. Participants will also be asked to complete quality of life and household cost questionnaires at selected visits. Study visits for participants who fail first-line treatment will occur at treatment failure, between Days 15 and 30, Week 4 post-treatment failure, every 4 weeks until Week 48 post-treatment failure, and every 12 weeks thereafter. A targeted physical exam, measurement of height and weight, TB infection screening, blood collection, pill counts, and compliance/adherence and resource utilization counseling will occur at most visits. Participants will also be asked to complete quality of life and household cost questionnaires at selected visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Behavioral: Monitoring by an HIV-trained medical doctor, Drug: Efavirenz, Drug: Lamivudine, Drug: Lopinavir/Ritonavir, Drug: Nevirapine, Drug: StavudineStudy-specified Antiretroviral regimen under care of HIV-trained medical doctor |
| B | Active comparator | Behavioral: Monitoring by an HIV-trained primary care nurse, Drug: Efavirenz, Drug: Lamivudine, Drug: Lopinavir/Ritonavir, Drug: Nevirapine, Drug: StavudineStudy-specified Antiretroviral regimen under care of HIV-trained primary care nurse |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- HIV-1 infected
- Current severe CDC Category B AIDS-defining illness (with the exception of a single episode of bacterial sepsis or a single episode of zoster), OR history of a severe CDC Category B or C AIDS-defining illness, OR one CD4 count less than 350 cells/mm3 within 6 months prior to study entry
- Antiretroviral naive. A participant who previously received 6 weeks or less of post-exposure prophylaxis or short course therapy for the prevention of mother-to-child transmission are not excluded. More information on this criterion can be found in the protocol.
- Willing to use acceptable forms of contraception
- Parent or guardian willing to provide informed consent, if applicable
Key exclusion criteria (10 listed)
- Current newly diagnosed CDC Category C AIDS-defining opportunistic infection or condition requiring acute therapy at the time of study entry. More information on this criterion can be found in the protocol.
- Therapy with agents with significant systemic myelosuppressive, neurotoxic, pancreatotoxic, hepatotoxic, or cytotoxic potential within 30 days prior to study entry
- Require certain medications
- Current alcohol or substance abuse that, in the opinion of the investigator, may interfere with the study
- Uncontrolled diarrhea (more than 6 stools per day for 7 consecutive days) within 30 days prior to study entry
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 |
|---|---|---|
| Monitoring by an HIV-trained medical doctorParticipants will receive care from an HIV-trained medical doctor | Behavioural | A |
| Monitoring by an HIV-trained primary care nurseParticipants will receive care from an HIV-trained primary care nurse | Behavioural | B |
| EfavirenzAlso: EFV600 mg tablet taken orally daily | Drug | A, B |
| LamivudineAlso: 3TC150 mg tablet taken orally daily | Drug | A, B |
| Lopinavir/RitonavirAlso: LPV/RTV400 mg lopinavir/100mg ritonavir tablet taken orally twice daily | Drug | A, B |
| NevirapineAlso: NVP200 mg tablet taken orally for 14 days before taking a 200 mg tablet orally twice daily | Drug | A, B |
| StavudineAlso: d4TTablet taken orally daily. Dosage depends on weight. | Drug | A, B |
Primary outcome
Cumulative Treatment Failure Rate of Participants on First Line Antiretroviral Therapy Monitored by Primary Health Care Nurses (Investigative Arm)is Not Inferior to the Cumulative Treatment Failure Rate of Participants Monitored by Doctors (Control Arm).
Time frame: 96 weeks
Cumulative treatment failure is a composite endpoint made up of death, virological failure, toxicity failure and protocol-defined loss to follow-up failure.
4 secondary outcomes
To Compare Subject Adherence to First Line Antiretroviral Treatment as Measured by Pill Count, Between the Two Primary Health Care Monitoring Models.
Time frame: Throughout study
Drug Resistance HIV Mutations, Defined by Demonstration of Virologic Failure
Time frame: Throughout the study
To Compare the Overall Clinical Safety of Antiretroviral Therapy, as Measured by the Occurrence of Clinical and Laboratory Grade 3 and 4 Adverse Events, Between Primary Health Care Monitoring Arms.
Time frame: Throughout study
To Estimate the Total and Incremental Costs, From the Provider and Societal Perspectives, of the Two Approaches (the Primary Health Care Sister and Doctor) to the Provision of Antiretrovirals in Primary Health Care Services in Each Study Site.
Time frame: Throughout study
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 12699015Hosseinipour MC, Kazembe PN, Sanne IM, van der Horst CM. Challenges in delivering antiretroviral treatment in resource poor countries. AIDS. 2002;16 Suppl 4:S177-87. doi: 10.1097/00002030-200216004-00024. No abstract available.
- Background: PubMed 15534564Sanne I, van der Horst C. Research as a path to wide-scale implementation of antiretroviral therapy in Africa. J HIV Ther. 2004 Sep;9(3):65-8.
- Background: PubMed 17032578Wools-Kaloustian K, Kimaiyo S. Extending HIV care in resource-limited settings. Curr HIV/AIDS Rep. 2006 Nov;3(4):182-6. doi: 10.1007/s11904-006-0014-1.
- Derived from this study: PubMed 22618567Brehm JH, Koontz DL, Wallis CL, Shutt KA, Sanne I, Wood R, McIntyre JA, Stevens WS, Sluis-Cremer N, Mellors JW; CIPRA-SA Project 1 Study Team. Frequent emergence of N348I in HIV-1 subtype C reverse transcriptase with failure of initial therapy reduces susceptibility to reverse-transcriptase inhibitors. Clin Infect Dis. 2012 Sep;55(5):737-45. doi: 10.1093/cid/cis501. Epub 2012 May 22.
- Derived from this study: PubMed 21685540Orrell C, Cohen K, Conradie F, Zeinecker J, Ive P, Sanne I, Wood R. Efavirenz and rifampicin in the South African context: is there a need to dose-increase efavirenz with concurrent rifampicin therapy? Antivir Ther. 2011;16(4):527-34. doi: 10.3851/IMP1780.
- Derived from this study: PubMed 20557927Sanne I, Orrell C, Fox MP, Conradie F, Ive P, Zeinecker J, Cornell M, Heiberg C, Ingram C, Panchia R, Rassool M, Gonin R, Stevens W, Truter H, Dehlinger M, van der Horst C, McIntyre J, Wood R; CIPRA-SA Study Team. Nurse versus doctor management of HIV-infected patients receiving antiretroviral therapy (CIPRA-SA): a randomised non-inferiority trial. Lancet. 2010 Jul 3;376(9734):33-40. doi: 10.1016/S0140-6736(10)60894-X.
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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.
James McIntyre, MBChB, MRCOG principal investigator
Perinatal HIV Research Unit, Chris Hani Baragwanath Hospital
Ian Sanne, MBChB principal investigator
University of the Witwatersrand, Thembaletu Clinic, Helen Joseph Hospital
Robin Wood, MBChB, FCP (SA) principal investigator
Department of Medicine, University of Cape Town
Questions about this trial
What is this clinical trial studying?
A study testing Monitoring by an HIV-trained medical doctor, Monitoring by an HIV-trained primary care nurse and Efavirenz in people with HIV Infections, run by CIPRA SA.
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 10 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 21 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 16 Jun 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Cumulative Treatment Failure Rate of Participants on First Line Antiretroviral Therapy Monitored by Primary Health Care Nurses (Investigative Arm)is Not Inferior to the Cumulative Treatment Failure Rate of Participants Monitored by Doctors (Control Arm). (time frame: 96 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 NCT00255840, which also lists 6 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 21 Jun 2011.