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Minocycline for HIV+ Cognitive Impairment in Uganda

28. januar 2011 oppdatert av: Johns Hopkins University

Minocycline in the Treatment of HIV-Associated Cognitive Impairment in Uganda

Purpose: The purpose of the study is to assess the safety and effectiveness of minocycline, an antibiotic, in the treatment of Human immunodeficiency virus (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 cluster of differentiation 4 (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 Objective:

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

Secondary Objectives:

  • 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

Studieoversikt

Status

Avsluttet

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

73

Fase

  • Fase 2
  • Fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Uganda
      • Kampala, Uganda
        • Infecious Diseas Institute

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 65 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • HIV infection prior to study entry
  • Naïve to any antiretroviral regimen and ineligible to receive antiretroviral therapy by cluster of differentiation 4 (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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Minocycline
Minocycline 100 mg orally every 12 hours
Legemiddel: minocycline
100 mg capsule every 12 hours by mouth
Placebo komparator: Placebo
Placebo minocycline capsules every 12 hours
Legemiddel: minocycline placebo capsule
1 capsule every 12 hours by mouth

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
24-week Change of Uganda Neuropsychological Test Battery Summary Measure (U NP Sum)
Tidsramme: At baseline and week 24
The U NP Sum is defined as the average of z scores for 9 neuropsychological test subcomponents in the neuropsychological test battery (i.e. the average of norm-adjusted ("z") scores for Grooved Pegboard Dominant Hand, Grooved Pegboard Non-dominant Hand, Color Trails 1, Color Trails 2, Symbol Digit, WHO-UCLA Verbal Learning test Trial 5, WHO-UCLA Verbal Learning test delayed recall, Digit Span forward and Digit Span backward). The outcome is defined as U NP Sum at week 24 - U NP Sum at baseline.
At baseline and week 24

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
24-week Change of Memorial Sloan Kettering (MSK) HIV Dementia Stage
Tidsramme: At baseline and week 24
The outcome is a new dichotomous variable: no change/worse vs. better at 24 weeks compared to baseline.
At baseline and week 24
24-week Change of Karnofsky Performance Score
Tidsramme: At baseline and week 24
The outcome is a new dichotomous variable: no change/worse vs. better at 24 weeks compared to baseline.
At baseline and week 24
Time From Treatment Initiation to the Development of a Grade ≥ 2 Toxicity and/or Sign and Symptoms.
Tidsramme: Time of initial Grade ≥ 2 toxicity and/or sign and symptom event up to week 24
The outcome is the time to first Grade ≥ 2 toxicity and/or sign and symptoms from study treatment initiation up to week 24. The grade was determined by clinicians and an Grade ≥ 2 event means moderate, severe, life-threatening, or death event.
Time of initial Grade ≥ 2 toxicity and/or sign and symptom event up to week 24
Time From Treatment Initiation to the Development of a Grade ≥ 2 Toxicity and/or Sign and Symptoms
Tidsramme: Time of first Grade ≥ 2 toxicity and/or sign and symptom event up to 48 weeks
The outcome is the time of first Grade ≥ 2 toxicity and/or sign and symptoms from treatment initiation up to 48 weeks. The grade was determined by clinicians and an Grade ≥ 2 event means moderate, severe, life-threatening, or death event.
Time of first Grade ≥ 2 toxicity and/or sign and symptom event up to 48 weeks
24-week Change of CD4 Cell Counts
Tidsramme: At baseline and week 24
The outcome is defined as CD4 cell count at week 24 - CD4 cell count at baseline. The unit is cells/mm^3.
At baseline and week 24
48-week Change of CD4 Cell Counts
Tidsramme: At baseline and week 48
The outcome is defined as CD4 cell count at week 48 - CD4 cell count at baseline. The unit is cells/mm^3.
At baseline and week 48
24-week Change of Instrumental Activities of Daily Living
Tidsramme: At baseline and week 24
The outcome is a new dichotomous variable: no change/worse vs. better at 24 weeks compared to baseline.
At baseline and week 24
24-week Change of HIV RNA Plasma Viral Loads (Log10 Transformed)
Tidsramme: At baseline and week 24
The outcome is the HIV RNA plasma viral loads (Log10 transformed) at week 24 - the viral loads (Log10 transformed) at baseline.
At baseline and week 24
24-week Change of Center for Epidemiologic Studies Depression (CES-D) Score
Tidsramme: At baseline and week 24

The outcome is the total CES-D score at week 24 - the total CES-D score at baseline.

The total CES-D score is based on 20 CES-D items, such as "I was bothered by things that usually don't bother me" and "I did not feel like eating, my appetite was poor". Patients were asked to answer each item by 4 scales: (1) Rarely, (2) Sometimes, (3) Occasionally, and (4) Most of the time. After 4 negative items were multiplied by -1, the total CES-D score is a simple sum of all items.

The min and Max are 0 and 60, respectively. Higher scores indicate more severe depressive symptoms.
At baseline and week 24

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Johns Hopkins University

Samarbeidspartnere

Makerere University

Etterforskere

  • Hovedetterforsker: Ned Sacktor, MD, Johns Hopkins School of Medicine

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. april 2008

Primær fullføring (Faktiske)

1. desember 2009

Studiet fullført (Faktiske)

1. desember 2009

Datoer for studieregistrering

Først innsendt

2. mars 2009

Først innsendt som oppfylte QC-kriteriene

2. mars 2009

Først lagt ut (Anslag)

3. mars 2009

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

25. februar 2011

Siste oppdatering sendt inn som oppfylte QC-kriteriene

28. januar 2011

Sist bekreftet

1. januar 2011

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • Uganda minocycline study
  • Grant Number: 5 UO1 NS32228

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