AIDSPhase 3NCT00197613
The Adult Antiretroviral Treatment and Resistance Study (Tshepo)
A Phase 3 study testing (A) zidovudine, lamivudine and nevirapine, (B) zidovudine, lamivudine and efavirenz and (C) zidovudine, didanosine, and nevirapine in people with AIDS and HIV Infection, run by Harvard School of Public Health (HSPH) at 1 site in Botswana.
Trial summary
The "Adult Antiretroviral Treatment and Resistance Study," hereafter referred to as "The Tshepo Study," is the first large-scale research study of antiretroviral therapy to treat AIDS and HIV infection in Botswana. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- AIDS, HIV Infection
- What is being tested?
- (A) zidovudine, lamivudine and nevirapine, (B) zidovudine, lamivudine and efavirenz and (C) zidovudine, didanosine, and nevirapine
- Type of treatment
- Surgery or procedure
- How many people
- 650 participants
- Where
- 1 siteBotswana
- Study dates
- Dec 2002to Dec 2007
- Phase
- Phase 3
- 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
Inclusion Criteria:(1) HIV infection indicated by (a) positive ELISA in two separate blood samples, the second no more than eight weeks prior to randomization), (b) CD4 cell count of less than 200 cells/ml OR CD4 cell count between 201-350 with plasma HIV-1 RNA level of greater than 55,000 copies/ml, (c) Karnofsky (performance) score greater than or equal to 50; (2) no history of previous antiretroviral therapy, except for zidovudine and/or single-dose nevirapine administered during pregnancy to prevent mother-to-child HIV transmission of HIV-1; (3) baseline hemoglobin of greater than or equal to 8.0 g/dl (4) baseline absolute neutrophil count greater than or equal to 1000 cells/mm3 (5) baseline serum creatinine level less than 200 micromol/L (6) baseline SGPT(ALT) less than 205 U/L and SGOT (AST) less than 170 U/L (7) baseline alkaline phosphatase level less than or equal to 330 U/L etc.
Trial locations and contacts
1 site in 1 country.
About this study
The "Adult Antiretroviral Treatment and Resistance Study," hereafter referred to as "The Tshepo Study," is the first large-scale research study of antiretroviral therapy to treat AIDS and HIV infection in Botswana. The Tshepo Study is an open-label, randomized study comparing: (1) the rate of development and specific types of drug resistance mutations with various antiretroviral combination therapies to HIV-1C, the subtype of HIV found in southern Africa, and (2) the short and long-term effectiveness of two operational modifications of Directly Observed Therapy (DOT) medication adherence strategies for antiretroviral therapy. Specifically, treatment follow-up via the Standard of Care, the national standard of care as it evolves in Botswana, with intensive clinic-based follow up including regular adherence education sessions, will be compared to Community-Based Directly Observed Therapy (Com-DOT). Com-DOT involves the SOC with added community or family-based DOT. This Com-DOT component would involve a trained, community or family-based Medication Partner ("mopati") who observes the patient take his or medications daily.
- Conditions
- AIDS, HIV Infection
- Being tested
- (A) zidovudine, lamivudine and nevirapine, (B) zidovudine, lamivudine and efavirenz, (C) zidovudine, didanosine, and nevirapine, (D) zidovudine, didanosine, and efavirenz, (E) stavudine, lamivudine, and nevirapine
- Medical subject headings
- Acquired Immunodeficiency Syndrome, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
(A) zidovudine, lamivudine and nevirapineDrug
(B) zidovudine, lamivudine and efavirenzDrug
(C) zidovudine, didanosine, and nevirapineDrug
(D) zidovudine, didanosine, and efavirenzDrug
(E) stavudine, lamivudine, and nevirapineDrug
(F) stavudine, lamivudine and efavirenzDrug
Adherence Strategy Standard of Care (SOC)Procedure or surgery
Adherence Strategy Community-Based DOTProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Virological failure, time to grade 3 or higher toxicity.
Secondary outcomes (1)
Time to drug resistance, rates of point mutations at virological failure, adherence to study medication.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startDec 2002
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AIDSStudies 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 3
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 650 participants
Sponsor and investigators
- Lead sponsor
- Harvard School of Public Health (HSPH)
- Sponsor type
- University, hospital or other
- Collaborators
- Princess Marina Hospital, Botswana, Botswana Ministry of Health, McGill University Health Centre/Research Institute of the McGill University Health Centre, Bristol-Myers Squibb
- Responsible party
- Principal investigator, Richard Marlink, Harvard School of Public Health (HSPH)
- Investigators
- Richard Marlink, MD, Principal investigator, Harvard School of Public Health AIDS Initiative
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00197613
- Sponsor's protocol ID
- HSC #0110THEA
- Status last verified
- Sep 2012
- First submitted
- 12 Sep 2005
- Last updated
- 17 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Adult Antiretroviral Treatment and Resistance Study (Tshepo)
- ClinicalTrials.gov ID
- NCT00197613
- Acronym / sponsor ID
- HSC #0110THEA
- Conditions
- AIDS, HIV Infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 650 participants
- Lead sponsor
- Harvard School of Public Health (HSPH)University, hospital or other
- Collaborators
- Princess Marina Hospital, Botswana, Botswana Ministry of Health, McGill University Health Centre/Research Institute of the McGill University Health Centre, Bristol-Myers Squibb
- Study start
- Dec 2002
- Study completion
- Dec 2007 (actual)
- First posted
- 20 Sep 2005 (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 "Adult Antiretroviral Treatment and Resistance Study," hereafter referred to as "The Tshepo Study," is the first large-scale research study of antiretroviral therapy to treat AIDS and HIV infection in Botswana. The Tshepo Study is an open-label, randomized study comparing: (1) the rate of development and specific types of drug resistance mutations with various antiretroviral combination therapies to HIV-1C, the subtype of HIV found in southern Africa, and (2) the short and long-term effectiveness of two operational modifications of Directly Observed Therapy (DOT) medication adherence strategies for antiretroviral therapy. Specifically, treatment follow-up via the Standard of Care, the national standard of care as it evolves in Botswana, with intensive clinic-based follow up including regular adherence education sessions, will be compared to Community-Based Directly Observed Therapy (Com-DOT). Com-DOT involves the SOC with added community or family-based DOT. This Com-DOT component would involve a trained, community or family-based Medication Partner ("mopati") who observes the patient take his or medications daily.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| (A) zidovudine, lamivudine and nevirapine | Drug | – |
| (B) zidovudine, lamivudine and efavirenz | Drug | – |
| (C) zidovudine, didanosine, and nevirapine | Drug | – |
| (D) zidovudine, didanosine, and efavirenz | Drug | – |
| (E) stavudine, lamivudine, and nevirapine | Drug | – |
| (F) stavudine, lamivudine and efavirenz | Drug | – |
| Adherence Strategy Standard of Care (SOC) | Procedure or surgery | – |
| Adherence Strategy Community-Based DOT | Procedure or surgery | – |
Primary outcome
Time to Virological failure, time to grade 3 or higher toxicity.
1 secondary outcome
Time to drug resistance, rates of point mutations at virological failure, adherence to study medication.
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 Sep 2012.
Related trials for AIDS
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.
Richard Marlink, MD principal investigator
Harvard School of Public Health AIDS Initiative
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing (A) zidovudine, lamivudine and nevirapine, (B) zidovudine, lamivudine and efavirenz and (C) zidovudine, didanosine, and nevirapine in people with AIDS and HIV Infection, run by Harvard School of Public Health (HSPH) at 1 site in Botswana.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 Sep 2012. 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 Botswana. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Time to Virological failure, time to grade 3 or higher toxicity.. 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 17 Sep 2012.