HIV InfectionNCT01064752
A Pilot Study of the Effect of Minocycline on Cerebrospinal Fluid HIV-1 Infection
An observational study of HIV Infection, run by University of California, San Francisco.
Trial summary
This will be an uncontrolled, open-labelled pilot study exploring whether minocycline has a measurable and selective effect on HIV infection of the central nervous system. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Infection
- What is being tested?
- Minocycline
- How many people
- 7 participants
- Where
- No sites listed yet
- Study dates
- Apr 2005to Oct 2009
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: HIV-infected subjects >18 years old not on antiretroviral therapy who are willing to volunteer to take minocycline and undergo the four study LPs and other evaluations recruited from the San Francisco Bay area.
Who may be able to join
- HIV infection with plasma and CSF HIV RNA concentrations (using Roche Amplicor assay) > 1,000 copies/ mL (available after baseline LP).
- Off antiretroviral therapy (ART) for > 6 weeks before the study and no plans to begin treatment for the study duration. (The decision of whether or not a subject takes antiretroviral therapy will be made by the subject in consultation with his/her primary care provider prior to screening for this study.)
- Predicted adherence to the medication.
- Capable of providing informed consent.
- > 18 years old
- CD4 cell counts >150 cells/μL (though likely most, if not all, will be >250 cells/μL).
- When available, subjects will be screened for stability of blood CD4 and HIV RNA levels.
Who cannot join
- Taking a tetracycline within 6 months or history of adverse reaction to minocycline or another tetracycline.
- Enhanced risk from lumbar puncture, including documented or suspected cerebral mass lesion predisposing to brain herniation or bleeding diathesis.
- Pregnancy or expectation of pregnancy during the study.
- Active opportunistic infection or active neurological disease that might confound evaluation.
- ADC Stage > 1.
- Hemoglobin < 10 Gms/dL.
- BUN or creatine above the normal limits.
- Taking other drugs known to reduce the metabolism of minocycline and thus increase the probability of toxicity.
About this study
This will be an uncontrolled, open-labelled pilot study exploring whether minocycline has a measurable and selective effect on HIV infection of the central nervous system.
Read the detailed description
This study is founded on a sequence of related hypotheses: 1. inflammatory responses related to activation of macrophages importantly contribute to the magnitude of CNS HIV infection by increasing the local production of viral progeny; 2. the tetracycline, minocycline, has anti-inflammatory properties which likely underlie studies showing that this drug can inhibit HIV-1 infection in macrophages and microglia in vitro and reduce simian immunodeficiency virus (SIV) encephalitis in macaques; 3. by reducing CNS monocyte/macrophage/microglial activation, minocycline will therefore reduce CNS HIV infection; 4. CSF will reflect or parallel (and thus serve as a 'model' of) brain infection and inflammation in this setting; 5. therefore, longitudinal CSF monitoring can assess the effect of minocycline on both CNS HIV infection and inflammation; 6. because the brain injury underlying AIDS dementia complex (ADC) and its pathological substrate, HIV encephalitis, critically involve inflammatory processes and, in the broad sense, immunopathology, minocycline might eventually prove useful as an adjunct to antiviral therapy in accelerating recovery from this condition (though importantly, this pilot study will not include ADC patients).
This will be an uncontrolled, open-labelled pilot study exploring whether minocycline has a measurable and selective effect on CSF HIV RNA concentration. There are no previous studies examining this effect in humans. We define a priori a 'biologically meaningful' effect to be an increase in the Δplasma-CSF HIV concentration of >0.5 log10 copies/mL of HIV RNA (i.e. an increase in the difference between plasma and CSF of >0.5 log10 copies/mL of HIV RNA compared to the baseline difference) in the face of unchanged or reduced plasma HIV RNA. Reductions in the absolute levels of CSF and plasma HIV as well as reductions in CSF inflammatory markers and T cell activation will also be of interest.
This study will serve as an initial exploration of the possible therapeutic effect of minocycline on CNS HIV infection. Our overall strategy is to begin with this pilot study, and if the results look promising (biological effect and lack of toxicity), to use these results to design a controlled trial, either as a single or multi-institutional study.
Additionally, this study shares an almost identical design with another proposed study examining the effects of atorvastatin on CSF HIV infection. While neither of these studies is controlled, they will yield pilot comparative results.
- Conditions
- HIV Infection
- Being tested
- Minocycline
- Keywords
- Minocycline, HIV-1, Immune activation, Cerebrospinal fluid, Observational
- Medical subject headings
- HIV Infections, cyclopia sequence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MinocyclineDrug
100 mg po bid for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Minocycline | HIV-1 infected, not on anti-retroviral medication Receives: Drug: Minocycline |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2010 (estimated)
- Study startApr 2005
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Investigators
- Richard W Price, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01064752
- Sponsor's protocol ID
- H9133-26156-04
- Status last verified
- Apr 2009
- First submitted
- 5 Feb 2010
- Last updated
- 8 Feb 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of the Effect of Minocycline on Cerebrospinal Fluid HIV-1 Infection
- ClinicalTrials.gov ID
- NCT01064752
- Acronym / sponsor ID
- H9133-26156-04
- Conditions
- HIV Infection
- Keywords
- Minocycline, HIV-1, Immune activation, Cerebrospinal fluid, Observational
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Apr 2005
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 8 Feb 2010 (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 will be an uncontrolled, open-labelled pilot study exploring whether minocycline has a measurable and selective effect on HIV infection of the central nervous system.
Detailed description
This study is founded on a sequence of related hypotheses: 1. inflammatory responses related to activation of macrophages importantly contribute to the magnitude of CNS HIV infection by increasing the local production of viral progeny; 2. the tetracycline, minocycline, has anti-inflammatory properties which likely underlie studies showing that this drug can inhibit HIV-1 infection in macrophages and microglia in vitro and reduce simian immunodeficiency virus (SIV) encephalitis in macaques; 3. by reducing CNS monocyte/macrophage/microglial activation, minocycline will therefore reduce CNS HIV infection; 4. CSF will reflect or parallel (and thus serve as a 'model' of) brain infection and inflammation in this setting; 5. therefore, longitudinal CSF monitoring can assess the effect of minocycline on both CNS HIV infection and inflammation; 6. because the brain injury underlying AIDS dementia complex (ADC) and its pathological substrate, HIV encephalitis, critically involve inflammatory processes and, in the broad sense, immunopathology, minocycline might eventually prove useful as an adjunct to antiviral therapy in accelerating recovery from this condition (though importantly, this pilot study will not include ADC patients).
This will be an uncontrolled, open-labelled pilot study exploring whether minocycline has a measurable and selective effect on CSF HIV RNA concentration. There are no previous studies examining this effect in humans. We define a priori a 'biologically meaningful' effect to be an increase in the Δplasma-CSF HIV concentration of >0.5 log10 copies/mL of HIV RNA (i.e. an increase in the difference between plasma and CSF of >0.5 log10 copies/mL of HIV RNA compared to the baseline difference) in the face of unchanged or reduced plasma HIV RNA. Reductions in the absolute levels of CSF and plasma HIV as well as reductions in CSF inflammatory markers and T cell activation will also be of interest.
This study will serve as an initial exploration of the possible therapeutic effect of minocycline on CNS HIV infection. Our overall strategy is to begin with this pilot study, and if the results look promising (biological effect and lack of toxicity), to use these results to design a controlled trial, either as a single or multi-institutional study.
Additionally, this study shares an almost identical design with another proposed study examining the effects of atorvastatin on CSF HIV infection. While neither of these studies is controlled, they will yield pilot comparative results.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Minocycline | – | Drug: MinocyclineHIV-1 infected, not on anti-retroviral medication |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- HIV-infected subjects >18 years old not on antiretroviral therapy who are willing to volunteer to take minocycline and undergo the four study LPs and other evaluations recruited from the San Francisco Bay area.
Key inclusion criteria (7 listed)
- HIV infection with plasma and CSF HIV RNA concentrations (using Roche Amplicor assay) > 1,000 copies/ mL (available after baseline LP).
- Off antiretroviral therapy (ART) for > 6 weeks before the study and no plans to begin treatment for the study duration. (The decision of whether or not a subject takes antiretroviral therapy will be made by the subject in consultation with his/her primary care provider prior to screening for this study.)
- Predicted adherence to the medication.
- Capable of providing informed consent.
- > 18 years old
Key exclusion criteria (8 listed)
- Taking a tetracycline within 6 months or history of adverse reaction to minocycline or another tetracycline.
- Enhanced risk from lumbar puncture, including documented or suspected cerebral mass lesion predisposing to brain herniation or bleeding diathesis.
- Pregnancy or expectation of pregnancy during the study.
- Active opportunistic infection or active neurological disease that might confound evaluation.
- ADC Stage > 1.
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 |
|---|---|---|
| Minocycline100 mg po bid for 8 weeks | Drug | Minocycline |
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 8 Feb 2010.
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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.
Richard W Price, MD principal investigator
University of California, San Francisco
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infection, run by University of California, San Francisco.
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 7 inclusion and 8 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 8 Feb 2010. 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 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?
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 8 Feb 2010.