HIV InfectionsNCT00703404
Response to Standard HIV Treatment in Bamako, Mali
An observational study of HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Mali.
Trial summary
This study will evaluate the effectiveness of first-line HIV treatment (fixed-dose combination of the generic antiretroviral drugs nevirapine, stavudine and lamivudine) provided by the Malian National HIV Treatment Program. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- How many people
- 76 participants
- Where
- 1 siteMali
- Study dates
- 18 Jun 2008to 24 Feb 2016
- 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
- HIV-infected adults (age greater than or equal to 18 years) naive to treatment with antiretroviral medications, who are to begin the regimen of government-sponsored antiretroviral treatment program or an alternate regimen in the case of HIV1 and HIV2 coinfected individuals.
- The sole exception to naive will be a history of use of peripartum single-dose nevirapine.
- Hemoglobin greater than or equal to 8 g/dL
- Ability and willingness to provide informed consent and ability to comply with study requirements and visit schedule.
- Must be willing to allow stored samples to be used in the future for studying HIV disease and immune function.
Who cannot join
- Serologic evidence of HIV-2 infection mono-infection.
- Tuberculosis of any form for which the patient is currently undergoing treatment with or requires a recommended regimen containing a rifamycin antibiotic.
- Baseline medical conditions that preclude the use of the Malian fixed-dose regimen, such as peripheral neuropathy of any etiology and pancreatic disease.
Trial locations and contacts
1 site in 1 country.
Mali1 site
University of Bamako, Faculty of Medicine, Pharmacy and Odontostomatology
Bamako
About this study
Official title: A Cohort Observational Study to Assess the Virologic Response to Standard HIV Treatment in Bamako, Mali
This study will evaluate the effectiveness of first-line HIV treatment (fixed-dose combination of the generic antiretroviral drugs nevirapine, stavudine and lamivudine) provided by the Malian National HIV Treatment Program. Antiretroviral therapy has become a priority because of its proven effectiveness in decreasing sickness and death from HIV infection. Reliable information on its efficacy is needed.
Patients 18 years of age and older who enter the Malian National HIV Treatment Program and have not had prior antiretroviral treatment may be eligible for this study.
Read more
Primary Objective
The primary objective is to measure the virologic treatment response at 24 weeks to the Malian-approved fixed-dose regimen (FDC) of nevirapine, stavudine and lamivudine (Triomune) in patients who are na(SqrRoot) ve to antiretroviral therapy in Bamako, Mali compared to a historical cohort as a prelude to further clinical research investigations in Mali.
Secondary Objectives
- To assess the association of the 24 week response with the response at one year as measured by suppression of viremia to less than 50 copies/mL
- To evaluate the baseline clinical and HIV-associated characteristics of a cohort of persons who are enrolled in protocol-mandated monitoring.
Participants undergo treatment in the government-sponsored program. Clinical visits are scheduled at study days 0 (antiviral therapy start day) and 14, and at 1, 3, 6, 9 and 12 months. Patients undergo a medical history, including all confirmed and probably diagnoses made since the previous visit and current status, physical examination and blood tests for CD4 and viral load at each visit.
Study start date: July 2008
Read the detailed description
This study will assess the efficacy of HIV treatment provided in accordance with the Malian National HIV Treatment Program. The Malian National HIV Treatment Program uses fixe dose coninaison (FDC) therapy, and this study will use a historical comparison from an African country in which the same generic antiretoviral are used. Virologic responses of patients enrolled in the Malian national program will be determined and, in a non-inferiority design, compared to these historical controls. The study will also establish the feasibility of doing frequent HIV virologic monitoring in this setting.
Viral RNA and CD4 T-cell count monitoring will be performed for HIV-infected persons seen at study sites. All clinical decision-making and prescription will occur outside of the protocol. Decisions about whether antiretroviral therapy is appropriate, the prescription of antiretroviral therapy, and the monitoring of treatment will be done by Malian health-care providers outside of the scope of the protocol. Viral RNA monitoring will be used to assess the endpoint of viral RNA suppression below the limit of detection (50 copies/mL).
- Conditions
- HIV Infections
- Keywords
- Anti-Retroviral Therapy, HIV, Virologic Response, Treatment Naïve
- Medical subject headings
- HIV Infections
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2008 (estimated)
- Study start18 Jun 2008
- Study completion24 Feb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies 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
- Time perspective
- Prospective
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Sophia B Siddiqui, M.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00703404
- Sponsor's protocol ID
- 999908160
- Other IDs
- 08-I-N160
- Status last verified
- 24 Feb 2016
- First submitted
- 20 Jun 2008
- Last updated
- 5 Apr 2018
- Results posted
- No
Publications
Demeter LM, Hughes MD, Coombs RW, Jackson JB, Grimes JM, Bosch RJ, Fiscus SA, Spector SA, Squires KE, Fischl MA, Hammer SM. Predictors of virologic and clinical outcomes in HIV-1-infected patients receiving concurrent treatment with indinavir, zidovudine, and lamivudine. AIDS Clinical Trials Group Protocol 320. Ann Intern Med. 2001 Dec 4;135(11):954-64. doi: 10.7326/0003-4819-135-11-200112040-00007.
PubMed 11730396Anekthananon T, Ratanasuwan W, Techasathit W, Sonjai A, Suwanagool S. Safety and efficacy of a simplified fixed-dose combination of stavudine, lamivudine and nevirapine (GPO-VIR) for the treatment of advanced HIV-infected patients: a 24-week study. J Med Assoc Thai. 2004 Jul;87(7):760-7.
PubMed 15521230Idigbe EO, Adewole TA, Eisen G, Kanki P, Odunukwe NN, Onwujekwe DI, Audu RA, Araoyinbo ID, Onyewuche JI, Salu OB, Adedoyin JA, Musa AZ. Management of HIV-1 infection with a combination of nevirapine, stavudine, and lamivudine: a preliminary report on the Nigerian antiretroviral program. J Acquir Immune Defic Syndr. 2005 Sep 1;40(1):65-9. doi: 10.1097/01.qai.0000159516.39982.1b.
PubMed 16123684
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cohort Observational Study to Assess the Virologic Response to Standard HIV Treatment in Bamako, Mali
- ClinicalTrials.gov ID
- NCT00703404
- Acronym / sponsor ID
- 999908160
- Conditions
- HIV Infections
- Keywords
- Anti-Retroviral Therapy, HIV, Virologic Response, Treatment Naïve
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 18 Jun 2008
- Study completion
- 24 Feb 2016
- First posted
- 23 Jun 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.
This study will evaluate the effectiveness of first-line HIV treatment (fixed-dose combination of the generic antiretroviral drugs nevirapine, stavudine and lamivudine) provided by the Malian National HIV Treatment Program. Antiretroviral therapy has become a priority because of its proven effectiveness in decreasing sickness and death from HIV infection. Reliable information on its efficacy is needed.
Patients 18 years of age and older who enter the Malian National HIV Treatment Program and have not had prior antiretroviral treatment may be eligible for this study.
Primary Objective
The primary objective is to measure the virologic treatment response at 24 weeks to the Malian-approved fixed-dose regimen (FDC) of nevirapine, stavudine and lamivudine (Triomune) in patients who are na(SqrRoot) ve to antiretroviral therapy in Bamako, Mali compared to a historical cohort as a prelude to further clinical research investigations in Mali.
Secondary Objectives
- To assess the association of the 24 week response with the response at one year as measured by suppression of viremia to less than 50 copies/mL
- To evaluate the baseline clinical and HIV-associated characteristics of a cohort of persons who are enrolled in protocol-mandated monitoring.
Participants undergo treatment in the government-sponsored program. Clinical visits are scheduled at study days 0 (antiviral therapy start day) and 14, and at 1, 3, 6, 9 and 12 months. Patients undergo a medical history, including all confirmed and probably diagnoses made since the previous visit and current status, physical examination and blood tests for CD4 and viral load at each visit.
Study start date: July 2008
Detailed description
This study will assess the efficacy of HIV treatment provided in accordance with the Malian National HIV Treatment Program. The Malian National HIV Treatment Program uses fixe dose coninaison (FDC) therapy, and this study will use a historical comparison from an African country in which the same generic antiretoviral are used. Virologic responses of patients enrolled in the Malian national program will be determined and, in a non-inferiority design, compared to these historical controls. The study will also establish the feasibility of doing frequent HIV virologic monitoring in this setting.
Viral RNA and CD4 T-cell count monitoring will be performed for HIV-infected persons seen at study sites. All clinical decision-making and prescription will occur outside of the protocol. Decisions about whether antiretroviral therapy is appropriate, the prescription of antiretroviral therapy, and the monitoring of treatment will be done by Malian health-care providers outside of the scope of the protocol. Viral RNA monitoring will be used to assess the endpoint of viral RNA suppression below the limit of detection (50 copies/mL).
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- HIV-infected adults (age greater than or equal to 18 years) naive to treatment with antiretroviral medications, who are to begin the regimen of government-sponsored antiretroviral treatment program or an alternate regimen in the case of HIV1 and HIV2 coinfected individuals.
- The sole exception to naive will be a history of use of peripartum single-dose nevirapine.
- Hemoglobin greater than or equal to 8 g/dL
- Ability and willingness to provide informed consent and ability to comply with study requirements and visit schedule.
- Must be willing to allow stored samples to be used in the future for studying HIV disease and immune function.
Key exclusion criteria (3 listed)
- Serologic evidence of HIV-2 infection mono-infection.
- Tuberculosis of any form for which the patient is currently undergoing treatment with or requires a recommended regimen containing a rifamycin antibiotic.
- Baseline medical conditions that preclude the use of the Malian fixed-dose regimen, such as peripheral neuropathy of any etiology and pancreatic disease.
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 5 Apr 2018.
- Background: PubMed 11730396Demeter LM, Hughes MD, Coombs RW, Jackson JB, Grimes JM, Bosch RJ, Fiscus SA, Spector SA, Squires KE, Fischl MA, Hammer SM. Predictors of virologic and clinical outcomes in HIV-1-infected patients receiving concurrent treatment with indinavir, zidovudine, and lamivudine. AIDS Clinical Trials Group Protocol 320. Ann Intern Med. 2001 Dec 4;135(11):954-64. doi: 10.7326/0003-4819-135-11-200112040-00007.
- Background: PubMed 15521230Anekthananon T, Ratanasuwan W, Techasathit W, Sonjai A, Suwanagool S. Safety and efficacy of a simplified fixed-dose combination of stavudine, lamivudine and nevirapine (GPO-VIR) for the treatment of advanced HIV-infected patients: a 24-week study. J Med Assoc Thai. 2004 Jul;87(7):760-7.
- Background: PubMed 16123684Idigbe EO, Adewole TA, Eisen G, Kanki P, Odunukwe NN, Onwujekwe DI, Audu RA, Araoyinbo ID, Onyewuche JI, Salu OB, Adedoyin JA, Musa AZ. Management of HIV-1 infection with a combination of nevirapine, stavudine, and lamivudine: a preliminary report on the Nigerian antiretroviral program. J Acquir Immune Defic Syndr. 2005 Sep 1;40(1):65-9. doi: 10.1097/01.qai.0000159516.39982.1b.
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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.
Sophia B Siddiqui, M.D. principal investigator
National Institute of Allergy and Infectious Diseases (NIAID)
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 Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Mali.
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 3 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 5 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 Mali. 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 NCT00703404, which also lists 3 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 5 Apr 2018.