A Pilot Study of the Effect of Minocycline on Cerebrospinal Fluid HIV-1 Infection
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01064752 |
Recruitment Status
:
Completed
First Posted
: February 8, 2010
Last Update Posted
: February 8, 2010
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment |
---|---|
HIV Infection | Drug: Minocycline |
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 Type : | Observational |
Actual Enrollment : | 7 participants |
Observational Model: | Case-Only |
Time Perspective: | Prospective |
Official Title: | A Pilot Study of the Effect of Minocycline on Cerebrospinal Fluid HIV-1 Infection |
Study Start Date : | April 2005 |
Actual Primary Completion Date : | October 2009 |
Actual Study Completion Date : | October 2009 |

Group/Cohort | Intervention/treatment |
---|---|
Minocycline
HIV-1 infected, not on anti-retroviral medication
|
Drug: Minocycline
100 mg po bid for 8 weeks
|

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01064752
Principal Investigator: | Richard W Price, MD | University of California, San Francisco |
Responsible Party: | Richard W. Price, MD, University of California San Francisco |
ClinicalTrials.gov Identifier: | NCT01064752 History of Changes |
Other Study ID Numbers: |
H9133-26156-04 |
First Posted: | February 8, 2010 Key Record Dates |
Last Update Posted: | February 8, 2010 |
Last Verified: | April 2009 |
Keywords provided by University of California, San Francisco:
Minocycline HIV-1 Immune activation Cerebrospinal fluid Observational |
Additional relevant MeSH terms:
Infection Communicable Diseases HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Minocycline Anti-Bacterial Agents Anti-Infective Agents |