Minocycline for HIV+ Cognitive Impairment in Uganda - Full Text View

Sponsor:	Johns Hopkins University
Collaborator:	Makerere University
Information provided by:	Johns Hopkins University
ClinicalTrials.gov Identifier:	NCT00855062

Purpose

Purpose: The purpose of the study is to assess the safety and effectiveness of minocycline, an antibiotic, in the treatment of HIV-associated cognitive impairment in Uganda.

Study Design: Treatment, 24-week Randomized, Placebo-Controlled, Double-Blind Phase with Optional 24-week Open Label Phase for Subjects with a CD4 Count in the 251-350 Range

Arm 1: Minocycline 100 mg orally every 12 hours (50 subjects)
Arm 2: Matching placebo orally every 12 hours (50 subjects)

Primary Outcome Measure:

· To examine whether minocycline treatment will improve cognitive performance after 24 weeks compared to baseline

Secondary Outcome Measures:

To examine whether minocycline treatment for 24 weeks is safe and well-tolerated in individuals with HIV-associated cognitive impairment
To examine whether minocycline treatment for 48 weeks is safe and well-tolerated in individuals with HIV-associated cognitive impairment
To examine whether minocycline treatment for 24 weeks improves functional impairment

Condition	Intervention	Phase
HIV-associated Cognitive Impairment HIV Infections	Drug: minocycline Drug: minocycline placebo capsule	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Minocycline in the Treatment of HIV-Associated Cognitive Impairment in Uganda

Resource links provided by NLM:

MedlinePlus related topics: AIDS

Drug Information available for: Minocycline Minocycline hydrochloride

U.S. FDA Resources

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:

· To examine whether minocycline treatment will improve cognitive performance after 24 weeks compared to baseline [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

· To examine whether minocycline treatment for 24 weeks is safe and well-tolerated in individuals with HIV-associated cognitive impairment [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
· To examine whether minocycline treatment for 48 weeks is safe and well-tolerated in individuals with HIV-associated cognitive impairment [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
· To examine whether minocycline treatment for 24 weeks improves functional impairment [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	April 2008
Estimated Study Completion Date:	August 2010
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Minocycline 100 mg q12 h: Active Comparator Active treatment with minocycline	Drug: minocycline 100 mg capsule q12 hours by mouth
2: Placebo Comparator placebo minocycline capsules	Drug: minocycline placebo capsule 1 capsule q 12 hours by mouth

Detailed Description:

Inclusion Criteria

HIV infection prior to study entry
Naïve to any antiretroviral regimen and ineligible to receive antiretroviral therapy by CD4 criteria in Uganda
Negative serum or urine pregnancy test for women of childbearing potential
Willingness to use birth control
Age 18-65 years
AIDS Dementia Scale Stage 0.5 OR 1
Impaired cognitive performance as evidenced by an International HIV Dementia Scale (HDS) as defined by the protocol
Ability to sit or stand and swallow intact capsules with an 8-ounce glass of water
Ability and willingness of subject or legal guardian/ representative to give written informed consent
Resident within a 20km radius of Kampala city

Exclusion Criteria

Current cancers other than basal cell carcinoma, in situ carcinoma of the cervix, or Kaposi's sarcoma without evidence of visceral involvement or which does not require systemic chemotherapy
Severe premorbid psychiatric illness, including schizophrenia and major depression which, in the in investigator's opinion, is likely to interfere with study compliance
Active symptomatic AIDS-defining opportunistic infection within 45 days prior to study entry
Confounding neurological disorders as defined in the protocol
Central nervous system infections or cancers as defined in the protocol
Systemic lupus
Thyroid disease diagnosed within 24 weeks prior to entry
Breastfeeding
Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements
Serious illness requiring systemic treatment and/or hospitalization until subject either completes therapy or is clinically stable on therapy, in the opinion of the investigator
History of allergy/sensitivity to minocycline or other tetracyclines and their formulations
Any other clinically significant condition or laboratory abnormality that, in the opinion of the investigator, would interfere with the subject's ability to participate in the study. This includes an individual found to have an HIV dementia scale stage 3 or 4.
Any esophageal or other condition that would interfere with the swallowing of the study medication
Use of excluded drugs as defined by the protocol

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

· HIV infection prior to study entry
- Naïve to any antiretroviral regimen and ineligible to receive antiretroviral therapy by CD4 criteria in Uganda
- Negative serum or urine pregnancy test for women of childbearing potential
- Willingness to use birth control
- Age 18-65 years
- AIDS Dementia Scale Stage 0.5 OR 1
- Impaired cognitive performance as evidenced by an International HIV Dementia Scale (HDS) as defined by the protocol
- Ability to sit or stand and swallow intact capsules with an 8-ounce glass of water
- Ability and willingness of subject or legal guardian/ representative to give written informed consent
- Resident within a 20km radius of Kampala city Exclusion Criteria
- Current cancers other than basal cell carcinoma, in situ carcinoma of the cervix, or Kaposi's sarcoma without evidence of visceral involvement or which does not require systemic chemotherapy
- Severe premorbid psychiatric illness, including schizophrenia and major depression which, in the in investigator's opinion, is likely to interfere with study compliance
- Active symptomatic AIDS-defining opportunistic infection within 45 days prior to study entry
- Confounding neurological disorders as defined in the protocol
- Central nervous system infections or cancers as defined in the protocol
- Systemic lupus
- Thyroid disease diagnosed within 24 weeks prior to entry
- Breastfeeding
- Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements
- Serious illness requiring systemic treatment and/or hospitalization until subject either completes therapy or is clinically stable on therapy, in the opinion of the investigator
- History of allergy/sensitivity to minocycline or other tetracyclines and their formulations
- Any other clinically significant condition or laboratory abnormality that, in the opinion of the investigator, would interfere with the subject's ability to participate in the study. This includes an individual found to have an HIV dementia scale stage 3 or 4.
- Any esophageal or other condition that would interfere with the swallowing of the study medication
- Use of excluded drugs as defined by the protocol

Exclusion Criteria:

-

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00855062

Contacts

Contact: Noeline Nakasujja, MD	(011) 256 41 430 7289	drnoeline@yahoo.com
Contact: Elly Katabira, MD		katabira@infocom.co.ug

Locations

Uganda
Infecious Diseas Institute	Recruiting
Kampala, Uganda
Principal Investigator: Noeline Nakasuijja, MD

Sponsors and Collaborators

Johns Hopkins University

Makerere University

Investigators

Principal Investigator:

Ned Sacktor, MD

Johns Hopkins School of Medicine

More Information

Additional Information:

Website of NARC, the sponsoring grant for this trial This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Johns Hopkins School of Medicine ( Ned Sacktor, MD )
Study ID Numbers:	Uganda minocycline study, Grant Number: 5 UO1 NS32228
Study First Received:	March 2, 2009
Last Updated:	September 8, 2009
ClinicalTrials.gov Identifier:	NCT00855062 History of Changes
Health Authority:	United States: Federal Government; United States: NINDS appointed Data Safety Monitoring Committee for the Neurologic AIDS Research Consortium

Keywords provided by Johns Hopkins University:

HIV
HIV associated cognitive impairment
HIV dementia

Uganda
AIDS
Treatment Naive

Additional relevant MeSH terms:

Anti-Infective Agents
Minocycline
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Immune System Diseases
Acquired Immunodeficiency Syndrome
Infection
Pharmacologic Actions
Cognition Disorders

Immunologic Deficiency Syndromes
Virus Diseases
Anti-Bacterial Agents
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
HIV Infections
Therapeutic Uses
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections

ClinicalTrials.gov processed this record on February 08, 2010