HIV InfectionsNCT00100568
Efavirenz and Lamivudine/Zidovudine for Treatment-Naive HIV Infected Adults in Senegal
A study testing Efavirenz and Lamivudine/zidovudine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in Senegal.
Trial summary
The purpose of this study is to determine the safety and effectiveness of the anti-HIV drugs efavirenz and lamivudine/zidovudine given to treatment-naive HIV-infected people in Dakar, Senegal. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Efavirenz and Lamivudine/zidovudine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 2 sitesSenegal
- Study dates
- Jul 2006to Jun 2009
- 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
- HIV-infected
- Have never taken ARV drugs
- CD4 count of 200 cells/mm3 or less within 30 days of study entry if asymptomatic OR CD4 count of 350 cells/mm3 or less within 60 days of study entry if CDC Category A or B clinical condition present OR clinical diagnosis of AIDS, regardless of CD4 count
- Willing to stay in the study area for the duration of the study
- Willing to use acceptable forms of contraception
Who cannot join
- HIV-2 infected
- Systemic chemotherapy (except interferon) within 6 months prior to study entry
- Current drug or alcohol abuse that, in the opinion of the investigator, may interfere with the study
- Serious illness, including any active AIDS-defining infection, active tuberculosis, malaria, or any illness requiring systemic treatment or hospitalization. People who have completed therapy or are clinically stable on therapy for at least 14 days prior to study entry are not excluded.
- Serious psychiatric problems within 60 days of study entry, including depression, suicidal thoughts or attempts, aggressive behavior, or psychosis-like symptoms
- Have taken certain medications within 30 days of study entry
- Pregnancy or breastfeeding
Trial locations and contacts
2 sites in 1 country.
Senegal2 sites
Centre National Hospitalier de Fann, Dakar CIPRA CRS
Dakar
Institut d'Hygiène Sociale, Dakar CIPRA CRS
Dakar
About this study
Official title: A Pilot Study of Safety, Effectiveness, and Adherence of Lamivudine/Zidovudine and Efavirenz (3TC/ZDV + EFV) to Treat HIV-1 Infection in Senegal
The purpose of this study is to determine the safety and effectiveness of the anti-HIV drugs efavirenz and lamivudine/zidovudine given to treatment-naive HIV-infected people in Dakar, Senegal.
Read the detailed description
Despite a relatively low prevalence of HIV infection, all HIV subtypes have been documented in Senegal. Data on mutations that confer resistance to antiretroviral (ARV) drugs are limited to HIV subtype B; adherence data are also limited. The study will evaluate the safety and efficacy of an ARV regimen given to treatment-naive HIV infected adults and adolescents. The study will also examine the characteristics of virologic failure and adherence in this treatment group. Participants will be recruited at two sites in Dakar, Senegal.
This study will last 96 weeks. At study entry, all participants will be given an ARV regimen of lamivudine/zidovudine twice daily and efavirenz once daily. If toxicity or treatment failure occurs, some participants may require changes in their ARV regimens. There will be 14 study visits during the study; a physical exam, blood collection, and sociodemographic and medication history assessments will occur at each visit. Participants will also be asked to complete quality-of-life and adherence questionnaires. An off-study visit will occur at approximately one month after Week 96, with assessments and procedures similar to visits during the study.
- Conditions
- HIV Infections
- Being tested
- Efavirenz, Lamivudine/zidovudine
- 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.
EfavirenzDrug
Also called EFV
600 mg tablet taken orally daily
Lamivudine/zidovudineDrug
Also called 3TC/ZDV
150mg lamivudine/300mg zidovudine tablet taken orally twice daily
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | All participants will be given an ARV regimen of lamivudine/zidovudine and efavirenz at study entry. If toxicity or treatment failure occurs, some participants may require changes in their ARV regimens. Receives: Drug: Efavirenz; Drug: Lamivudine/zidovudine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Virologic efficacy, defined as HIV-1 viral load less than 200 copies/ml
Measured: Through Week 24
Treatment-related toxicity of Grade 3 or higher as measured by development of drug-related toxicities severe enough to warrant dose modification, interruption, or permanent discontinuation
Measured: Through Week 24
Secondary outcomes (10)
Virologic efficacy
Measured: At Weeks 48 and 96
Treatment related toxicity
Measured: At Weeks 48 and 96
Virologic failure, defined as HIV-1 viral load greater than 1,000 copies/ml
Measured: Throughout study
CD4 counts and HIV-1 RNA viral load
Measured: Throughout study
First new or recurrent AIDS-defining event (as defined by the CDC Expanded AIDS Surveillance Case definition) or death
Measured: Throughout study
Treatment discontinuation, defined as premature discontinuation of participation in the study, failure to take ARV therapy for 8 or more consecutive weeks, or to switch to another ARV regimen for any reason during the full course of the study
Measured: Throughout study
Genotypic resistance measured by at least 1 genotypic mutation associated with resistance among subjects with a confirmed virologic failure (as described previously) and evaluation of genotypic drug resistance patterns
Measured: At Weeks 24 and 96
Treatment adherence, defined by 95% or greater of prescribed pills taken
Measured: Throughout study
Quality of life as measured by items and patterns of responses to the FAHI questionnaire
Measured: Throughout study
HIV-1 DNA and RNA measurements
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 posted4 Jan 2005 (estimated)
- Study startJul 2006
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Initiative Senegalaise d'Acces aux Antiretroviraux (ISAARV)
- Responsible party
- Sponsor
- Investigators
- Souleymane Mboup, PharmD, Study chair, Laboratoire de Bacteriologic et de Virologie, Hospital Le Dantec Avenue Pasteur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00100568
- Sponsor's protocol ID
- CIPRA-SN-001
- Other IDs
- SN-CIPRA-001, 10412
- Status last verified
- Sep 2013
- First submitted
- 3 Jan 2005
- Last updated
- 6 Sep 2013
- Results posted
- No
Publications
Meda N, Ndoye I, M'Boup S, Wade A, Ndiaye S, Niang C, Sarr F, Diop I, Carael M. Low and stable HIV infection rates in Senegal: natural course of the epidemic or evidence for success of prevention? AIDS. 1999 Jul 30;13(11):1397-405. doi: 10.1097/00002030-199907300-00018.
PubMed 10449294DeJesus E, Herrera G, Teofilo E, Gerstoft J, Buendia CB, Brand JD, Brothers CH, Hernandez J, Castillo SA, Bonny T, Lanier ER, Scott TR; CNA30024 Study Team. Abacavir versus zidovudine combined with lamivudine and efavirenz, for the treatment of antiretroviral-naive HIV-infected adults. Clin Infect Dis. 2004 Oct 1;39(7):1038-46. doi: 10.1086/424009. Epub 2004 Sep 10.
PubMed 15472858
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Safety, Effectiveness, and Adherence of Lamivudine/Zidovudine and Efavirenz (3TC/ZDV + EFV) to Treat HIV-1 Infection in Senegal
- ClinicalTrials.gov ID
- NCT00100568
- Acronym / sponsor ID
- CIPRA-SN-001
- Conditions
- HIV Infections
- Keywords
- Treatment Naive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Initiative Senegalaise d'Acces aux Antiretroviraux (ISAARV)
- Study start
- Jul 2006
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 4 Jan 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 purpose of this study is to determine the safety and effectiveness of the anti-HIV drugs efavirenz and lamivudine/zidovudine given to treatment-naive HIV-infected people in Dakar, Senegal.
Detailed description
Despite a relatively low prevalence of HIV infection, all HIV subtypes have been documented in Senegal. Data on mutations that confer resistance to antiretroviral (ARV) drugs are limited to HIV subtype B; adherence data are also limited. The study will evaluate the safety and efficacy of an ARV regimen given to treatment-naive HIV infected adults and adolescents. The study will also examine the characteristics of virologic failure and adherence in this treatment group. Participants will be recruited at two sites in Dakar, Senegal.
This study will last 96 weeks. At study entry, all participants will be given an ARV regimen of lamivudine/zidovudine twice daily and efavirenz once daily. If toxicity or treatment failure occurs, some participants may require changes in their ARV regimens. There will be 14 study visits during the study; a physical exam, blood collection, and sociodemographic and medication history assessments will occur at each visit. Participants will also be asked to complete quality-of-life and adherence questionnaires. An off-study visit will occur at approximately one month after Week 96, with assessments and procedures similar to visits during the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Efavirenz, Drug: Lamivudine/zidovudineAll participants will be given an ARV regimen of lamivudine/zidovudine and efavirenz at study entry. If toxicity or treatment failure occurs, some participants may require changes in their ARV regimens. |
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
- Have never taken ARV drugs
- CD4 count of 200 cells/mm3 or less within 30 days of study entry if asymptomatic OR CD4 count of 350 cells/mm3 or less within 60 days of study entry if CDC Category A or B clinical condition present OR clinical diagnosis of AIDS, regardless of CD4 count
- Willing to stay in the study area for the duration of the study
- Willing to use acceptable forms of contraception
Key exclusion criteria (7 listed)
- HIV-2 infected
- Systemic chemotherapy (except interferon) within 6 months prior to study entry
- Current drug or alcohol abuse that, in the opinion of the investigator, may interfere with the study
- Serious illness, including any active AIDS-defining infection, active tuberculosis, malaria, or any illness requiring systemic treatment or hospitalization. People who have completed therapy or are clinically stable on therapy for at least 14 days prior to study entry are not excluded.
- Serious psychiatric problems within 60 days of study entry, including depression, suicidal thoughts or attempts, aggressive behavior, or psychosis-like symptoms
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 |
|---|---|---|
| EfavirenzAlso: EFV600 mg tablet taken orally daily | Drug | 1 |
| Lamivudine/zidovudineAlso: 3TC/ZDV150mg lamivudine/300mg zidovudine tablet taken orally twice daily | Drug | 1 |
Primary outcome
Virologic efficacy, defined as HIV-1 viral load less than 200 copies/ml
Time frame: Through Week 24
Treatment-related toxicity of Grade 3 or higher as measured by development of drug-related toxicities severe enough to warrant dose modification, interruption, or permanent discontinuation
Time frame: Through Week 24
10 secondary outcomes
Virologic efficacy
Time frame: At Weeks 48 and 96
Treatment related toxicity
Time frame: At Weeks 48 and 96
Virologic failure, defined as HIV-1 viral load greater than 1,000 copies/ml
Time frame: Throughout study
CD4 counts and HIV-1 RNA viral load
Time frame: Throughout study
First new or recurrent AIDS-defining event (as defined by the CDC Expanded AIDS Surveillance Case definition) or death
Time frame: Throughout study
Treatment discontinuation, defined as premature discontinuation of participation in the study, failure to take ARV therapy for 8 or more consecutive weeks, or to switch to another ARV regimen for any reason during the full course of the study
Time frame: Throughout study
Genotypic resistance measured by at least 1 genotypic mutation associated with resistance among subjects with a confirmed virologic failure (as described previously) and evaluation of genotypic drug resistance patterns
Time frame: At Weeks 24 and 96
Treatment adherence, defined by 95% or greater of prescribed pills taken
Time frame: Throughout study
Quality of life as measured by items and patterns of responses to the FAHI questionnaire
Time frame: Throughout study
HIV-1 DNA and RNA measurements
Time frame: Throughout study
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 6 Sep 2013.
- Background: PubMed 10449294Meda N, Ndoye I, M'Boup S, Wade A, Ndiaye S, Niang C, Sarr F, Diop I, Carael M. Low and stable HIV infection rates in Senegal: natural course of the epidemic or evidence for success of prevention? AIDS. 1999 Jul 30;13(11):1397-405. doi: 10.1097/00002030-199907300-00018.
- Background: PubMed 15472858DeJesus E, Herrera G, Teofilo E, Gerstoft J, Buendia CB, Brand JD, Brothers CH, Hernandez J, Castillo SA, Bonny T, Lanier ER, Scott TR; CNA30024 Study Team. Abacavir versus zidovudine combined with lamivudine and efavirenz, for the treatment of antiretroviral-naive HIV-infected adults. Clin Infect Dis. 2004 Oct 1;39(7):1038-46. doi: 10.1086/424009. Epub 2004 Sep 10.
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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.
Souleymane Mboup, PharmD study chair
Laboratoire de Bacteriologic et de Virologie, Hospital Le Dantec Avenue Pasteur
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Efavirenz and Lamivudine/zidovudine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in Senegal.
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 7 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 6 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Senegal. 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?
Virologic efficacy, defined as HIV-1 viral load less than 200 copies/ml (time frame: Through Week 24). The study lists 2 primary outcomes in all. 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 NCT00100568, which also lists 2 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 6 Sep 2013.