HIVNCT00341393
Validation of System for Monitoring the Effectiveness of Antiretroviral Therapy in HIV-Infected Patients in Africa
An observational study of HIV, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Uganda.
Trial summary
This study will evaluate a system for predicting the effectiveness of antiretroviral treatment in African HIV clinics where standard testing methods for measuring viral load, such as RNA polymerase chain reaction, are not available or affordable. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV
- How many people
- 0 participants
- Where
- 1 siteUganda
- Study dates
- 16 Feb 2006to 15 Nov 2007
- Phase
- Observational
- 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
- Willing to provide individual informed consent.
- HIV positive. (HIV status will have been confirmed by recognised external testing centre (eg AIC) or if necessary by the IDI lab using Abbott Determine HIV1-2 plus STAT-PAK (Chembio Diagnostic Systems) rapid tests. Unigold (Trinity Biotech) is available for 'tie-breaker' testing if necessary.
- Currently being followed at the Adult Infectious Disease Clinic.
- Patients who are aged 18 years or more.
- Patients on ART for more than 6 months who are PI naive.
Who cannot join
- Inability or unwillingness to provide individual informed consent.
- Patients currently admitted to 'Urgent Care' facility.
- Age less than 18 years.
- Patients enrolled in either 'Clinic' or 'Gates 5B' cohorts.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of Algorithm for Monitoring the Virological Efficacy of Antiretroviral Therapy in Africa
This study will evaluate a system for predicting the effectiveness of antiretroviral treatment in African HIV clinics where standard testing methods for measuring viral load, such as RNA polymerase chain reaction, are not available or affordable. Without accurate tests to monitor viral load, treatment decisions often are based on insufficient clinical and immunologic information. This study will see if combined analysis of patients' antiretroviral treatment history, adherence to treatment, clinical findings and simple laboratory tests can predict whether their treatment is effectively lowering their viral load. An effective monitoring system such as this could reduce the number of patients kept on ineffective treatments for prolonged periods of time as well as reduce the development of drug resistance.
HIV-infected patients 18 years of age and older who are being followed in the Adult Infectious Disease Clinic at Makerere University, Kampala, Uganda, and who have been taking antiretroviral treatment for more than 6 months may be eligible for this study.
Participants' medical charts are reviewed and their medical history is taken, including questions about their treatment history, adherence to treatment, and changes in symptoms. A blood sample is drawn to determine viral load, CD4+ and CBC counts, and, if necessary, anti-viral resistance.
Read the detailed description
Routine virological monitoring of HIV-infected patients on antiretroviral therapy (ART) is not currently affordable or available in most African HIV clinics using standard methods such as RNA polymerase chain reaction (PCR). Alternative cheaper technologies to quantify the viral load are still awaited. Therefore the majority of patients are monitored just clinically and sometimes immunologically. Decisions about switching to second-line ART for treatment failure are based upon insensitive (for virological failure) clinical and immunological criteria, such as those suggested by the World Health Organization (WHO).
We hypothesize that using a combination of detailed treatment and adherence history and changes in clinical and laboratory parameters, virological failure or success may be predicted in the majority of patients taking ART in a typical African HIV clinic. Using a monitoring algorithm in which patients are classified according to their likelihood of failure, it would be possible to reduce the number of viral loads required by an ART clinic while at the same time increasing the detection of those failing virologically, enabling a switch to a new effective regimen earlier than would be possible using the WHO criteria.
Therefore, the protocol team proposes a cross-sectional study of patients being treated in a busy African HIV clinic. We will include protease-inhibitor (PI)-naive patients who are on first-line non-nucleoside reverse transcriptase inhibitors (NNRTI) based ART and have been on treatment for more than 6 months. Each patient will undergo a structured interview, have their notes reviewed and have blood taken for complete blood count, CD4+, viral load and genotypic and phenotypic anti-viral resistance testing (if necessary).
Treatment, adherence, clinical and laboratory parameters would then be individually and collectively assessed for their ability to predict virological failure using various statistical procedures including a classification and regression tree (CART) analysis. From this, the monitoring algorithm would be refined. Its performance would then be compared against the current WHO recommendations for switching therapy to see what proportion of patients failing virologically could be switched earlier using this system and at what extra cost.
Such a monitoring system could reduce the number of patients being allowed to fail their first-line regimens for prolonged periods of time, for an affordable increase in cost. This could, therefore, reduce the evolution and transmission of drug resistance and significantly prolong the effectiveness of the roll out of ART in Africa.
- Conditions
- HIV
- Keywords
- HIV Infection, AIDS, Viral Load, Retroviral Treatment, Uganda
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2006 (estimated)
- Study start16 Feb 2006
- Study completion15 Nov 2007
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 HIVStudies 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
- Observational
- Enrolment
- 0 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00341393
- Sponsor's protocol ID
- 999906101
- Other IDs
- 06-I-N101
- Status last verified
- 15 Nov 2007
- First submitted
- 19 Jun 2006
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Smith CJ, Staszewski S, Sabin CA, Nelson M, Dauer B, Gute P, Johnson MA, Phillips AN, Gazzard B. Use of viral load measured after 4 weeks of highly active antiretroviral therapy to predict virologic outcome at 24 weeks for HIV-1-positive individuals. J Acquir Immune Defic Syndr. 2004 Sep 1;37(1):1155-9. doi: 10.1097/01.qai.0000135958.80919.e4.
PubMed 15319675
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Algorithm for Monitoring the Virological Efficacy of Antiretroviral Therapy in Africa
- ClinicalTrials.gov ID
- NCT00341393
- Acronym / sponsor ID
- 999906101
- Conditions
- HIV
- Keywords
- HIV Infection, AIDS, Viral Load, Retroviral Treatment, Uganda
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 0 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 16 Feb 2006
- Study completion
- 15 Nov 2007
- First posted
- 21 Jun 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.
This study will evaluate a system for predicting the effectiveness of antiretroviral treatment in African HIV clinics where standard testing methods for measuring viral load, such as RNA polymerase chain reaction, are not available or affordable. Without accurate tests to monitor viral load, treatment decisions often are based on insufficient clinical and immunologic information. This study will see if combined analysis of patients' antiretroviral treatment history, adherence to treatment, clinical findings and simple laboratory tests can predict whether their treatment is effectively lowering their viral load. An effective monitoring system such as this could reduce the number of patients kept on ineffective treatments for prolonged periods of time as well as reduce the development of drug resistance.
HIV-infected patients 18 years of age and older who are being followed in the Adult Infectious Disease Clinic at Makerere University, Kampala, Uganda, and who have been taking antiretroviral treatment for more than 6 months may be eligible for this study.
Participants' medical charts are reviewed and their medical history is taken, including questions about their treatment history, adherence to treatment, and changes in symptoms. A blood sample is drawn to determine viral load, CD4+ and CBC counts, and, if necessary, anti-viral resistance.
Detailed description
Routine virological monitoring of HIV-infected patients on antiretroviral therapy (ART) is not currently affordable or available in most African HIV clinics using standard methods such as RNA polymerase chain reaction (PCR). Alternative cheaper technologies to quantify the viral load are still awaited. Therefore the majority of patients are monitored just clinically and sometimes immunologically. Decisions about switching to second-line ART for treatment failure are based upon insensitive (for virological failure) clinical and immunological criteria, such as those suggested by the World Health Organization (WHO).
We hypothesize that using a combination of detailed treatment and adherence history and changes in clinical and laboratory parameters, virological failure or success may be predicted in the majority of patients taking ART in a typical African HIV clinic. Using a monitoring algorithm in which patients are classified according to their likelihood of failure, it would be possible to reduce the number of viral loads required by an ART clinic while at the same time increasing the detection of those failing virologically, enabling a switch to a new effective regimen earlier than would be possible using the WHO criteria.
Therefore, the protocol team proposes a cross-sectional study of patients being treated in a busy African HIV clinic. We will include protease-inhibitor (PI)-naive patients who are on first-line non-nucleoside reverse transcriptase inhibitors (NNRTI) based ART and have been on treatment for more than 6 months. Each patient will undergo a structured interview, have their notes reviewed and have blood taken for complete blood count, CD4+, viral load and genotypic and phenotypic anti-viral resistance testing (if necessary).
Treatment, adherence, clinical and laboratory parameters would then be individually and collectively assessed for their ability to predict virological failure using various statistical procedures including a classification and regression tree (CART) analysis. From this, the monitoring algorithm would be refined. Its performance would then be compared against the current WHO recommendations for switching therapy to see what proportion of patients failing virologically could be switched earlier using this system and at what extra cost.
Such a monitoring system could reduce the number of patients being allowed to fail their first-line regimens for prolonged periods of time, for an affordable increase in cost. This could, therefore, reduce the evolution and transmission of drug resistance and significantly prolong the effectiveness of the roll out of ART in Africa.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
Key exclusion criteria (4 listed)
- Inability or unwillingness to provide individual informed consent.
- Patients currently admitted to 'Urgent Care' facility.
- Age less than 18 years.
- Patients enrolled in either 'Clinic' or 'Gates 5B' cohorts.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 2 Jul 2017.
- Background: PubMed 15319675Smith CJ, Staszewski S, Sabin CA, Nelson M, Dauer B, Gute P, Johnson MA, Phillips AN, Gazzard B. Use of viral load measured after 4 weeks of highly active antiretroviral therapy to predict virologic outcome at 24 weeks for HIV-1-positive individuals. J Acquir Immune Defic Syndr. 2004 Sep 1;37(1):1155-9. doi: 10.1097/01.qai.0000135958.80919.e4.
Related trials for HIV
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Uganda.
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 4 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 2 Jul 2017. 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 Uganda. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00341393, 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 2 Jul 2017.