HIV InfectionsNCT00053404
Immunologic Control of Drug Resistant HIV
An observational study of HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
Drug resistant HIV strains often develop in patients who have taken anti-HIV drugs for an extended time. However, these drug resistant HIV strains do not always cause an increase in the level of HIV in the blood. This study will explore why some patients with drug resistant virus continue to have low viral loads. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2003to Dec 2008
- 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
Study population: HIV-infected participants receiving antiretroviral therapy
Who may be able to join
- HIV-infected for at least 6 months prior to study entry
- Documented pretherapy or off-therapy viral load of more than 10,000 copies/ml on at least 2 occasions or more than 20,000 copies/ml on at least 1 occasion
- At least a 70% reduction in plasma HIV RNA levels from pretherapy baseline
- Stable highly active antiretroviral therapy (HAART) regimen for at least 4 months prior to study entry
- HIV viral load of 200 to 10,000 copies/ml for 3 months prior to study entry
- CD4 count greater than 100 cells/mm3 and a nadir CD4 count less than 500 cells/mm3
Show all 9Show fewer
- Virologic failure as defined by DHHS guidelines on at least one HAART regimen prior to the study entry HAART regimen
- Documented adherence to antiretroviral therapy
- Two major resistance mutations to at least two antiretroviral drug classes
Who cannot join
- Significant toxicity on current HAART regimen
Trial locations and contacts
1 site in 1 country.
United States1 site
San Francisco General Hospital
San Francisco, California, 94110
About this study
Official title: Observational Study of HIV Infected Adults With Detectable Plasma HIV-1 RNA Levels Between 200 and 10,000 Copies/mL While Receiving Stable Antiretroviral Therapy
Drug resistant HIV strains often develop in patients who have taken anti-HIV drugs for an extended time. However, these drug resistant HIV strains do not always cause an increase in the level of HIV in the blood. This study will explore why some patients with drug resistant virus continue to have low viral loads.
Read the detailed description
Despite the emergence of high level drug resistance in HIV-infected patients on stable antiretroviral therapy, plasma HIV RNA levels generally remain below the pretherapy viral load "set-point". The virologic and immunologic determinants of this lower steady state level of viremia have not been defined. Preliminary data indicate that: 1) drug resistant variants have reduced replicative capacity and pathogenic potential; 2) drug resistant viremia is associated with reduced T cell activation and turnover compared to wild-type viremia; and 3) patients with low level drug resistant viremia often have HIV-specific CD4 cells that are absent in patients with higher levels of viremia. This study will investigate whether the emergence of a poorly fit, drug resistant variant results in the generation of an effective HIV-specific CD4 cell response and if this response contributes to the establishment of a lower steady state level of viremia.
Participants in this study will be followed for 2 years or until antiretroviral therapy is modified or discontinued. Study visits will occur every 2 months, for a total of 14 visits. Study visits will include a patient interview and blood tests to measure the breadth and magnitude of the HIV-specific CD4 and CD8 cell responses as a function of viral load, viral replicative capacity, drug resistance phenotype, T cell turnover, and thymic function.
- Conditions
- HIV Infections
- Keywords
- Treatment Experienced, Drug Resistance
- 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 posted29 Jan 2003 (estimated)
- Study startMar 2003
- Primary completionDec 2006
- Study completionDec 2008 (estimated)
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 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Steven G. Deeks, MD, Study chair, Department of Medicine, University of California - San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00053404
- Sponsor's protocol ID
- 1R01AI052745-01
- Other IDs
- 1R01AI052745-01
- Status last verified
- Sep 2008
- First submitted
- 28 Jan 2003
- Last updated
- 26 Sep 2008
- Results posted
- No
Publications
Emu B, Sinclair E, Favre D, Moretto WJ, Hsue P, Hoh R, Martin JN, Nixon DF, McCune JM, Deeks SG. Phenotypic, functional, and kinetic parameters associated with apparent T-cell control of human immunodeficiency virus replication in individuals with and without antiretroviral treatment. J Virol. 2005 Nov;79(22):14169-78. doi: 10.1128/JVI.79.22.14169-14178.2005.
PubMed 16254352
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of HIV Infected Adults With Detectable Plasma HIV-1 RNA Levels Between 200 and 10,000 Copies/mL While Receiving Stable Antiretroviral Therapy
- ClinicalTrials.gov ID
- NCT00053404
- Acronym / sponsor ID
- 1R01AI052745-01
- Conditions
- HIV Infections
- Keywords
- Treatment Experienced, Drug Resistance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Mar 2003
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2008 (estimated)
- First posted
- 29 Jan 2003 (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.
Drug resistant HIV strains often develop in patients who have taken anti-HIV drugs for an extended time. However, these drug resistant HIV strains do not always cause an increase in the level of HIV in the blood. This study will explore why some patients with drug resistant virus continue to have low viral loads.
Detailed description
Despite the emergence of high level drug resistance in HIV-infected patients on stable antiretroviral therapy, plasma HIV RNA levels generally remain below the pretherapy viral load "set-point". The virologic and immunologic determinants of this lower steady state level of viremia have not been defined. Preliminary data indicate that: 1) drug resistant variants have reduced replicative capacity and pathogenic potential; 2) drug resistant viremia is associated with reduced T cell activation and turnover compared to wild-type viremia; and 3) patients with low level drug resistant viremia often have HIV-specific CD4 cells that are absent in patients with higher levels of viremia. This study will investigate whether the emergence of a poorly fit, drug resistant variant results in the generation of an effective HIV-specific CD4 cell response and if this response contributes to the establishment of a lower steady state level of viremia.
Participants in this study will be followed for 2 years or until antiretroviral therapy is modified or discontinued. Study visits will occur every 2 months, for a total of 14 visits. Study visits will include a patient interview and blood tests to measure the breadth and magnitude of the HIV-specific CD4 and CD8 cell responses as a function of viral load, viral replicative capacity, drug resistance phenotype, T cell turnover, and thymic function.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HIV-infected participants receiving antiretroviral therapy
Key inclusion criteria (9 listed)
- HIV-infected for at least 6 months prior to study entry
- Documented pretherapy or off-therapy viral load of more than 10,000 copies/ml on at least 2 occasions or more than 20,000 copies/ml on at least 1 occasion
- At least a 70% reduction in plasma HIV RNA levels from pretherapy baseline
- Stable highly active antiretroviral therapy (HAART) regimen for at least 4 months prior to study entry
- HIV viral load of 200 to 10,000 copies/ml for 3 months prior to study entry
Key exclusion criteria (1 listed)
- Significant toxicity on current HAART regimen
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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2008.
- Results publication: PubMed 16254352Emu B, Sinclair E, Favre D, Moretto WJ, Hsue P, Hoh R, Martin JN, Nixon DF, McCune JM, Deeks SG. Phenotypic, functional, and kinetic parameters associated with apparent T-cell control of human immunodeficiency virus replication in individuals with and without antiretroviral treatment. J Virol. 2005 Nov;79(22):14169-78. doi: 10.1128/JVI.79.22.14169-14178.2005.
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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.
Steven G. Deeks, MD study chair
Department of Medicine, University of California - San Francisco
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 United States.
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 9 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 26 Sep 2008. 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 United States. 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?
Results are not available in the source record.
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 NCT00053404, 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 26 Sep 2008.