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AzTrials

Mycobacterium Avium-intracellulare InfectionPhase 2NCT00000641

A Phase II/III Trial of Rifampin, Ciprofloxacin, Clofazimine, Ethambutol, and Amikacin in the Treatment of Disseminated Mycobacterium Avium Infection in HIV-Infected Individuals.

A Phase 2 study testing Ciprofloxacin hydrochloride, Ethambutol hydrochloride and Amikacin sulfate in people with Mycobacterium Avium-intracellulare Infection and HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 16 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To compare the effectiveness and toxicity of two combination drug treatment programs for the treatment of disseminated Mycobacterium avium infection in HIV seropositive patients. Read more about this study

Who is it for?
Ages 13 years and older
What is being tested?
Ciprofloxacin hydrochloride, Ethambutol hydrochloride and Amikacin sulfate
How many people
90 participants
Where
16 sitesUnited States
Study dates
Start not givento Dec 1994
Phase
Phase 2
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 13 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Concurrent Medication:
  • Allowed:
  • Zidovudine (AZT) and didanosine (ddI). Dideoxycytidine (ddC), EPO, and other experimental therapies granted Treatment IND or Expanded Access status, with the exception of rifabutin.
  • Concurrent therapies (acute and maintenance) for opportunistic infections not specifically prohibited.
  • Concurrent Treatment:
  • Allowed:
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  • Interferon-alfa.
  • Patients must have the following:
  • HIV infections or diagnosis of AIDS as per CDC classification.
  • Mycobacterium avium isolated from blood.
  • Capability of signing an informed consent, or consent of guardian if < 18 years of age.
  • Ability and willingness to participate in all components of the study and receive all study therapies.
  • Prior Medication:
  • Allowed:
  • Interferon-alfa.
  • Single drug prophylaxis for Mycobacterium avium or M. tuberculosis within the previous 4 weeks.

Who cannot join

  • Co-existing Condition:
  • Patients with the following symptoms or conditions are excluded:
  • Treatment Phase:
  • Known or suspected allergy to any of the study medications. Severe hearing loss.
  • Maintenance Phase:
  • Severe hearing loss. Hypersensitivity to macrolides. Intolerance to ethambutol and clofazimine.
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  • Concurrent Medication:
  • Excluded:
  • Acute therapy for other opportunistic infections at time of study entry.
  • Nephrotoxic agents such as amphotericin B, intravenous vancomycin, or foscarnet during the first 4 weeks of study therapy without specific exemption from one of the protocol chairs. Antacids within 2 hours of ingestion of study drugs.
  • Immunomodulators (except interferon-alfa) and other antimycobacterial drugs (including quinolones and aminoglycosides).
  • All experimental therapies (except ddI, ddC, and other experimental agents granted "Treatment IND" or "expanded access" status) will be prohibited (specific exemptions must be obtained from one of the protocol chairs).
  • Patients with the following are excluded:
  • Known or suspected allergy to any of the study medications. Cannot take drugs orally.
  • Severe hearing loss, at the discretion of the investigator.
  • Prior Medication:
  • Excluded:
  • Antimycobacterial drugs (including azithromycin, clarithromycin, rifamycins, quinolones, and aminoglycosides) or immunomodulators (except interferon-alfa) within 4 weeks prior to entry, except single-drug prophylaxis specifically allowed.
  • History of unreliable drug intake.
  • Inability to cooperate in the testing procedures.

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

United States16 sites

  • Unc Aids Crs

    Chapel Hill, North Carolina, 27599

  • Univ. of Cincinnati CRS

    Cincinnati, Ohio, 45267

  • Case CRS

    Cleveland, Ohio, 44106

  • Duke Univ. Med. Ctr. Adult CRS

    Durham, North Carolina, 27710

  • Regional Center for Infectious Disease, Wendover Medical Center CRS

    Greensboro, North Carolina

  • Indiana Univ. School of Medicine, Infectious Disease Research Clinic

    Indianapolis, Indiana, 46202

  • NY Univ. HIV/AIDS CRS

    New York, New York, 10016

  • Beth Israel Med. Ctr. (Mt. Sinai)

    New York, New York

  • NYU Med. Ctr., Dept. of Medicine

    New York, New York

  • NJ Med. School CRS

    Newark, New Jersey, 07103

  • Pitt CRS

    Pittsburgh, Pennsylvania, 15213

  • Univ. of Rochester ACTG CRS

    Rochester, New York, 14642

  • University of Washington AIDS CRS

    Seattle, Washington, 98122

  • St. Louis ConnectCare, Infectious Diseases Clinic

    St Louis, Missouri

  • Washington U CRS

    St Louis, Missouri

  • Harbor-UCLA Med. Ctr. CRS

    Torrance, California, 90502

Other trials in United States

About this study

To compare the effectiveness and toxicity of two combination drug treatment programs for the treatment of disseminated Mycobacterium avium infection in HIV seropositive patients. [Per 03/06/92 amendment: to evaluate the efficacy of azithromycin when given in conjunction with either ethambutol or clofazimine as maintenance therapy.] Disseminated M. avium infection is the most common systemic bacterial infection complicating AIDS in the United States. The prognosis of patients with disseminated M. avium is extremely poor, particularly when it follows other opportunistic infections or is associated with anemia. Test tube studies and clinical data indicate that the best treatment program may include clofazimine, ethambutol, a rifamycin derivative, and ciprofloxacin. Test tube and animal studies indicate that amikacin is a bactericidal (bacteria destroying) drug that works better when used with ciprofloxacin. Its role in treatment programs is a key issue because of toxicity and because it must be administered parenterally (by injection or intravenously).

Read the detailed description

Disseminated M. avium infection is the most common systemic bacterial infection complicating AIDS in the United States. The prognosis of patients with disseminated M. avium is extremely poor, particularly when it follows other opportunistic infections or is associated with anemia. Test tube studies and clinical data indicate that the best treatment program may include clofazimine, ethambutol, a rifamycin derivative, and ciprofloxacin. Test tube and animal studies indicate that amikacin is a bactericidal (bacteria destroying) drug that works better when used with ciprofloxacin. Its role in treatment programs is a key issue because of toxicity and because it must be administered parenterally (by injection or intravenously).

Patients undergo an initial 2-week observation period (days 1 - 14) during which time baseline evaluations are performed and type and severity of symptoms are monitored. Eligible patients are randomized on day 15 to one of two treatment programs: (1) ciprofloxacin, clofazimine, ethambutol, and rifampin (all taken orally), or (2) the same four drugs plus amikacin. Only patients for whom blood cultures obtained on either day 1 or day 14/15 are positive by week 6 continue on study drugs. Patients receive combination therapy for 24 weeks. Patients may have an indwelling central venous catheter in place for long-term administration of intravenous drug. PER 03/06/92 AMENDMENT: Newly enrolled patients who demonstrate a complete or partial clinical response at the end of study week 10 (8 weeks of drug therapy) discontinue their current regimen and begin maintenance therapy with azithromycin plus either ethambutol or clofazimine for an additional 24 weeks. Patients who do not demonstrate a response at study week 10 are discontinued from all study therapy. Patients enrolled on earlier versions of the protocol who have surpassed study week 16 (14 weeks of drug therapy) continue treatment with their originally assigned regimen through study week 26; those who have not surpassed study week 16 are considered for inclusion in the maintenance phase of the study.

Being tested
Ciprofloxacin hydrochloride, Ethambutol hydrochloride, Amikacin sulfate, Azithromycin, Rifampin
Keywords
Rifampin, Mycobacterium avium-intracellulare Infection, Drug Evaluation, Drug Therapy, Combination, Ethambutol, Clofazimine, Acquired Immunodeficiency Syndrome, Amikacin, Azithromycin, Ciprofloxacin
Medical subject headings
Mycobacterium avium-intracellulare Infection, HIV Infections, Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ciprofloxacin hydrochlorideDrug

  • Ethambutol hydrochlorideDrug

  • Amikacin sulfateDrug

  • AzithromycinDrug

  • RifampinDrug

  • ClofazimineDrug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2001 (estimated)
  2. Study completionDec 1994

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Masking
None (open label)
Enrolment
90 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00000641
Sponsor's protocol ID
ACTG 135
Other IDs
11110
Status last verified
Oct 2021
First submitted
2 Nov 1999
Last updated
3 Nov 2021
Results posted
No

Publications

  • Parent D, Ellner J, Hafner R, Williams M, Jacobs P, Hojczyk P. A phase II/III trial of Rifampin (RIF) Ciprofloxach (CIPRO), Clofazimine (CLOF), Ethambutol (ETH), +/- Amikacin (AK) in the treatment (RX) of Disseminated Mycobacterium avium (MA) infection in HIV-infected individuals (PTS). Natl Conf Hum Retroviruses Relat Infect (2nd). 1995 Jan 29-Feb 2:56

  • Ellner JJ, Goldberger MJ, Parenti DM. Mycobacterium avium infection and AIDS: a therapeutic dilemma in rapid evolution. J Infect Dis. 1991 Jun;163(6):1326-35. doi: 10.1093/infdis/163.6.1326.

    PubMed 2037799

  • Parenti DM, Williams PL, Hafner R, Jacobs MR, Hojczyk P, Hooton TM, Barber TW, Simpson G, van der Horst C, Currier J, Powderly WG, Limjoco M, Ellner JJ. A phase II/III trial of antimicrobial therapy with or without amikacin in the treatment of disseminated Mycobacterium avium infection in HIV-infected individuals. AIDS Clinical Trials Group Protocol 135 Study Team. AIDS. 1998 Dec 24;12(18):2439-46. doi: 10.1097/00002030-199818000-00013.

    PubMed 9875582

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ciprofloxacin hydrochloride, Ethambutol hydrochloride and Amikacin sulfate in people with Mycobacterium Avium-intracellulare Infection and HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 16 sites 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 16 inclusion and 20 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 3 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

On the ClinicalTrials.gov record for NCT00000641, which also lists 3 linked publications.

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 3 Nov 2021.

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