HIV InfectionsNCT00087464
Three Month Course of Anti-HIV Medications for People Recently Infected With HIV
A study testing Emtricitabine, Nevirapine and Tenofovir disoproxil fumarate in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID).
Trial summary
Short-term therapy may reduce the amount of HIV in the blood of adults recently infected with HIV. The purpose of this study is to see whether it is better for people to take a short course of anti-HIV drugs when they are first infected or if it is better to wait until the HIV infection causes health problems before… 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?
- Emtricitabine, Nevirapine and Tenofovir disoproxil fumarate
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- 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
- Acute or early HIV infection, as determined by the NIH Acute Infection and Early Disease Research Program (AIEDRP) definition
- Coenrolled in AIEDRP CORE01 trial
- Willing to use acceptable methods of contraception
Who cannot join
- Any severe medical illness that, in the opinion of the investigator, will interfere with the ability to adhere to therapy or will result in making therapy too risky for the patient
- Significant psychiatric illness or ongoing substance abuse that, in the opinion of the investigator, will compromise the ability of the patient to follow study procedures safely and consistently
- Hepatitis B or C infection AND liver enzymes of Grade 2 or greater OR evidence or history of severe hepatitis or cirrhosis
- Creatinine clearance less than 50 ml/min
- Received more than one month of prior antiretroviral therapy. Women who received short-term dosing of nevirapine to prevent mother-to-child transmission during childbirth are not excluded if they meet other study requirements. They should only be given nevirapine as part of an initial study regimen if resistance testing can be done to confirm that they do not have nevirapine resistance.
- Coenrolled in any other HIV treatment or investigational drug trial
- Pregnant or breastfeeding
About this study
Official title: Tenofovir, Emtricitabine, and Nevirapine for Recently HIV-Infected Subjects: Can Short-Course, Once Daily Therapy Reduce the Viral Load at 12 Months From Estimated Date of Infection?
Short-term therapy may reduce the amount of HIV in the blood of adults recently infected with HIV. The purpose of this study is to see whether it is better for people to take a short course of anti-HIV drugs when they are first infected or if it is better to wait until the HIV infection causes health problems before taking anti-HIV drugs.
Read the detailed description
Limited access to HIV treatment is a major problem in many parts of the world. If a well tolerated anti-HIV regimen with convenient once-daily dosing is effective in reducing viral load in people with recent or early HIV infection, this regimen could be used globally for controlling HIV. This study will determine the effectiveness of a three-month antiretroviral regimen in reducing viral load in HIV infected adults who were recently infected or have recently seroconverted. This study will recruit participants from Alabama and Tennessee in the United States and in Lusaka, Zambia.
Participants in this study must also be enrolled in the AIEDRP CORE01 study. Participants in this study will be divided into Early and Acute groups. Participants in the Early group will be people who have recently seroconverted; participants in the Acute group will be people with primary HIV infection. All participants will choose to receive the once-daily dosing regimen of emtricitabine, nevirapine, and tenofovir disoproxil fumarate. Didanosine, efavirenz, and stavudine may be substituted for other drugs in the regimen at the investigator's discretion. Participants will take the three-drug regimen for 90 days. If a participant's CD4 count is higher than 350 cells/mm3 at Day 90, the participant will stop therapy. If a participant's CD4 count is 350 cells/mm3 or lower at Day 90, or if the participant's CD4 count drops to 350 cells/mm3 or lower while therapy is stopped, the participant will receive an additional 30 days of therapy. This therapy strategy may be repeated as necessary up to Day 180. All participants taking the three-drug regimen will be followed, regardless of whether or not they have taken the regimen beyond Day 90.
In addition to AIEDRP CORE01's study visits, 7 additional study visits will occur at pretreatment, on Day 3, and at Weeks 1, 3, 8, 16, and 20. Blood collection will occur at all study visits. Data from study participants will be compared with data from a historical cohort of previously identified HIV infected adults with acute or early infection who did not receive treatment but were followed prospectively.
- Conditions
- HIV Infections
- Being tested
- Emtricitabine, Nevirapine, Tenofovir disoproxil fumarate
- Keywords
- Acute Infection, Treatment Naive, Treatment Interruption
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EmtricitabineDrug
NevirapineDrug
Tenofovir disoproxil fumarateDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2004 (estimated)
Why it stopped: study was withdrawn before any participants were recruited and enrolled
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
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- J. Michael Kilby, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00087464
- Sponsor's protocol ID
- AI-08-005
- Other IDs
- 11534, AIEDRP AI-08-005
- Status last verified
- Oct 2021
- First submitted
- 8 Jul 2004
- Last updated
- 1 Nov 2021
- Results posted
- No
Publications
Babiker A, Darbyshire J, Pezzotti P, Porter K, Prins M, Sabin C, Walker AS; CASCADE Collaboration. Short-term CD4 cell response after highly active antiretroviral therapy initiated at different times from seroconversion in 1,500 seroconverters. J Acquir Immune Defic Syndr. 2003 Mar 1;32(3):303-10. doi: 10.1097/00126334-200303010-00010.
PubMed 12626891van Leth F, Phanuphak P, Ruxrungtham K, Baraldi E, Miller S, Gazzard B, Cahn P, Lalloo UG, van der Westhuizen IP, Malan DR, Johnson MA, Santos BR, Mulcahy F, Wood R, Levi GC, Reboredo G, Squires K, Cassetti I, Petit D, Raffi F, Katlama C, Murphy RL, Horban A, Dam JP, Hassink E, van Leeuwen R, Robinson P, Wit FW, Lange JM; 2NN Study team. Comparison of first-line antiretroviral therapy with regimens including nevirapine, efavirenz, or both drugs, plus stavudine and lamivudine: a randomised open-label trial, the 2NN Study. Lancet. 2004 Apr 17;363(9417):1253-63. doi: 10.1016/S0140-6736(04)15997-7.
PubMed 15094269
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tenofovir, Emtricitabine, and Nevirapine for Recently HIV-Infected Subjects: Can Short-Course, Once Daily Therapy Reduce the Viral Load at 12 Months From Estimated Date of Infection?
- ClinicalTrials.gov ID
- NCT00087464
- Acronym / sponsor ID
- AI-08-005
- Conditions
- HIV Infections
- Keywords
- Acute Infection, Treatment Naive, Treatment Interruption
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: study was withdrawn before any participants were recruited and enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- First posted
- 13 Jul 2004 (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.
Short-term therapy may reduce the amount of HIV in the blood of adults recently infected with HIV. The purpose of this study is to see whether it is better for people to take a short course of anti-HIV drugs when they are first infected or if it is better to wait until the HIV infection causes health problems before taking anti-HIV drugs.
Detailed description
Limited access to HIV treatment is a major problem in many parts of the world. If a well tolerated anti-HIV regimen with convenient once-daily dosing is effective in reducing viral load in people with recent or early HIV infection, this regimen could be used globally for controlling HIV. This study will determine the effectiveness of a three-month antiretroviral regimen in reducing viral load in HIV infected adults who were recently infected or have recently seroconverted. This study will recruit participants from Alabama and Tennessee in the United States and in Lusaka, Zambia.
Participants in this study must also be enrolled in the AIEDRP CORE01 study. Participants in this study will be divided into Early and Acute groups. Participants in the Early group will be people who have recently seroconverted; participants in the Acute group will be people with primary HIV infection. All participants will choose to receive the once-daily dosing regimen of emtricitabine, nevirapine, and tenofovir disoproxil fumarate. Didanosine, efavirenz, and stavudine may be substituted for other drugs in the regimen at the investigator's discretion. Participants will take the three-drug regimen for 90 days. If a participant's CD4 count is higher than 350 cells/mm3 at Day 90, the participant will stop therapy. If a participant's CD4 count is 350 cells/mm3 or lower at Day 90, or if the participant's CD4 count drops to 350 cells/mm3 or lower while therapy is stopped, the participant will receive an additional 30 days of therapy. This therapy strategy may be repeated as necessary up to Day 180. All participants taking the three-drug regimen will be followed, regardless of whether or not they have taken the regimen beyond Day 90.
In addition to AIEDRP CORE01's study visits, 7 additional study visits will occur at pretreatment, on Day 3, and at Weeks 1, 3, 8, 16, and 20. Blood collection will occur at all study visits. Data from study participants will be compared with data from a historical cohort of previously identified HIV infected adults with acute or early infection who did not receive treatment but were followed prospectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Acute or early HIV infection, as determined by the NIH Acute Infection and Early Disease Research Program (AIEDRP) definition
- Coenrolled in AIEDRP CORE01 trial
- Willing to use acceptable methods of contraception
Key exclusion criteria (7 listed)
- Any severe medical illness that, in the opinion of the investigator, will interfere with the ability to adhere to therapy or will result in making therapy too risky for the patient
- Significant psychiatric illness or ongoing substance abuse that, in the opinion of the investigator, will compromise the ability of the patient to follow study procedures safely and consistently
- Hepatitis B or C infection AND liver enzymes of Grade 2 or greater OR evidence or history of severe hepatitis or cirrhosis
- Creatinine clearance less than 50 ml/min
- Received more than one month of prior antiretroviral therapy. Women who received short-term dosing of nevirapine to prevent mother-to-child transmission during childbirth are not excluded if they meet other study requirements. They should only be given nevirapine as part of an initial study regimen if resistance testing can be done to confirm that they do not have nevirapine resistance.
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 |
|---|---|---|
| Emtricitabine | Drug | – |
| Nevirapine | Drug | – |
| Tenofovir disoproxil fumarate | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2021.
- Background: PubMed 12626891Babiker A, Darbyshire J, Pezzotti P, Porter K, Prins M, Sabin C, Walker AS; CASCADE Collaboration. Short-term CD4 cell response after highly active antiretroviral therapy initiated at different times from seroconversion in 1,500 seroconverters. J Acquir Immune Defic Syndr. 2003 Mar 1;32(3):303-10. doi: 10.1097/00126334-200303010-00010.
- Background: PubMed 15094269van Leth F, Phanuphak P, Ruxrungtham K, Baraldi E, Miller S, Gazzard B, Cahn P, Lalloo UG, van der Westhuizen IP, Malan DR, Johnson MA, Santos BR, Mulcahy F, Wood R, Levi GC, Reboredo G, Squires K, Cassetti I, Petit D, Raffi F, Katlama C, Murphy RL, Horban A, Dam JP, Hassink E, van Leeuwen R, Robinson P, Wit FW, Lange JM; 2NN Study team. Comparison of first-line antiretroviral therapy with regimens including nevirapine, efavirenz, or both drugs, plus stavudine and lamivudine: a randomised open-label trial, the 2NN Study. Lancet. 2004 Apr 17;363(9417):1253-63. doi: 10.1016/S0140-6736(04)15997-7.
- Click here for more information about AIEDRP CORE01Link provided by the sponsor.
Related trials for HIV Infections
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.
J. Michael Kilby, MD principal investigator
University of Alabama at Birmingham
Questions about this trial
What is this clinical trial studying?
A study testing Emtricitabine, Nevirapine and Tenofovir disoproxil fumarate in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID).
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 3 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: withdrawn, as of the sponsor's last update on 1 Nov 2021. 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?
The study was withdrawn before enrolling participants, so there are no results.
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 NCT00087464, 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 1 Nov 2021.