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Pneumonia, Pneumocystis CariniiPhase 3NCT00000802

A Randomized, Comparative Study of Daily Dapsone and Daily Atovaquone for Prophylaxis Against PCP in HIV-Infected Patients Who Are Intolerant of Trimethoprim and/or Sulfonamides

A Phase 3 study testing Atovaquone and Dapsone in people with Pneumonia, Pneumocystis Carinii and HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 44 sites in 2 countries.

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 efficacy and safety of dapsone versus atovaquone in preventing or delaying the onset of histologically proven or probable Pneumocystis carinii pneumonia in HIV-infected patients with CD4 counts <= 200 cells/mm3 or <= 15 percent of the total lymphocyte count who are intolerant to trimethoprim and/or… Read more about this study

Who is it for?
Ages 13 years and older
What is being tested?
Atovaquone and Dapsone
How many people
700 participants
Where
44 sitesin 2 countries
Study dates
Start not givento Jul 1997
Phase
Phase 3
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: Strongly recommended:
  • Pyrimethamine (50 mg) and folinic acid (15 mg) weekly in patients receiving dapsone who have CD4 count < 100 cells/mm3 and are toxoplasmosis seropositive.
  • Patients must have:
  • Working diagnosis of HIV infection.
  • CD4 count <= 200 cells/mm3 or <= 15 percent of total lymphocyte count at any time in the past OR a history of PCP.
  • History of intolerance of trimethoprim and/or sulfonamides that required permanent discontinuation.
Show all 11Show fewer
  • NOTE:
  • Pregnant patients are eligible at the clinician's discretion.
  • Prior Medication:
  • Allowed:
  • Prior PCP prophylaxis.

Who cannot join

  • Co-existing Condition:
  • Patients with the following symptoms or conditions are excluded:
  • Active pneumocystosis.
  • Concurrent Medication:
  • Excluded:
  • PCP prophylaxis (other than study drug) or any medication with potential anti-PCP activity.
  • Patients with the following prior conditions are excluded:
  • Known treatment-limiting reaction to dapsone or atovaquone.

Trial locations and contacts

44 sites in 2 countries.

44 sites in 2 countries

United States43 sites

  • Emory Univ. Hemophilia Program Office

    Atlanta, Georgia, 303652225

  • University of Colorado Hospital CRS

    Aurora, Colorado, 80262

  • Johns Hopkins Adult AIDS CRS

    Baltimore, Maryland, 21287

  • Alabama Therapeutics CRS

    Birmingham, Alabama, 35294

  • Bmc Actg Crs

    Boston, Massachusetts, 02118

  • Beth Israel Deaconess - East Campus A0102 CRS

    Boston, Massachusetts, 02215

  • Massachusetts General Hospital ACTG CRS

    Boston, Massachusetts

  • SUNY - Buffalo, Erie County Medical Ctr.

    Buffalo, New York, 13210

  • Unc Aids Crs

    Chapel Hill, North Carolina

  • Carolinas HealthCare System, Carolinas Med. Ctr.

    Charlotte, North Carolina, 28203

  • Northwestern University CRS

    Chicago, Illinois, 60611

  • Cook County Hosp. CORE Ctr.

    Chicago, Illinois, 60612

  • Rush Univ. Med. Ctr. ACTG CRS

    Chicago, Illinois, 60612

  • Weiss Memorial Hosp.

    Chicago, Illinois, 60640

  • Univ. of Cincinnati CRS

    Cincinnati, Ohio

  • Case CRS

    Cleveland, Ohio, 44106

  • MetroHealth CRS

    Cleveland, Ohio

  • The Ohio State Univ. AIDS CRS

    Columbus, Ohio, 432101228

  • Regional Center for Infectious Disease, Wendover Medical Center CRS

    Greensboro, North Carolina, 27401

  • Queens Med. Ctr.

    Honolulu, Hawaii, 96816

  • Univ. of Hawaii at Manoa, Leahi Hosp.

    Honolulu, Hawaii, 96816

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

    Indianapolis, Indiana, 462025250

  • Univ. of Iowa Healthcare, Div. of Infectious Diseases

    Iowa City, Iowa, 52242

  • USC CRS

    Los Angeles, California, 900331079

  • Univ. of Miami AIDS CRS

    Miami, Florida, 331361013

  • Hennepin County Med. Ctr., Div. of Infectious Diseases

    Minneapolis, Minnesota, 55415

  • University of Minnesota, ACTU

    Minneapolis, Minnesota, 55455

  • Beth Israel Med. Ctr. (Mt. Sinai)

    New York, New York

  • NY Univ. HIV/AIDS CRS

    New York, New York

  • Univ. of Nebraska Med. Ctr., Durham Outpatient Ctr.

    Omaha, Nebraska

  • Stanford CRS

    Palo Alto, California, 943055107

  • Hosp. of the Univ. of Pennsylvania CRS

    Philadelphia, Pennsylvania, 19104

  • Wake County Health and Human Services CRS

    Raleigh, North Carolina, 27610

  • Univ. of Rochester ACTG CRS

    Rochester, New York, 14642

  • Ucsd, Avrc Crs

    San Diego, California, 921036325

  • Ucsf Aids Crs

    San Francisco, California, 941102859

  • Santa Clara Valley Med. Ctr.

    San Jose, California, 951282699

  • San Mateo County AIDS Program

    San Mateo, California

  • University of Washington AIDS CRS

    Seattle, Washington, 981224304

  • St. Louis ConnectCare, Infectious Diseases Clinic

    St Louis, Missouri

  • Washington U CRS

    St Louis, Missouri

  • Harbor-UCLA Med. Ctr. CRS

    Torrance, California, 90502

  • Howard University Hosp., Div. of Infectious Diseases, ACTU

    Washington D.C., District of Columbia, 20059

Other trials in United States

Tanzania1 site

  • Mbeya Med. Research Program, Mbeya Referral Hosp. CRS

    Mbeya

Other trials in Tanzania

About this study

To compare the efficacy and safety of dapsone versus atovaquone in preventing or delaying the onset of histologically proven or probable Pneumocystis carinii pneumonia in HIV-infected patients with CD4 counts <= 200 cells/mm3 or <= 15 percent of the total lymphocyte count who are intolerant to trimethoprim and/or sulfonamides.

Trimethoprim/sulfamethoxazole (TMP/SMX), which is effective for secondary PCP prophylaxis, is associated with allergic manifestations and side effects that limit its use. Patients who are intolerant of TMP/SMX require an effective alternative. Dapsone and atovaquone have both shown promise as PCP prophylactic agents.

Read the detailed description

Trimethoprim/sulfamethoxazole (TMP/SMX), which is effective for secondary PCP prophylaxis, is associated with allergic manifestations and side effects that limit its use. Patients who are intolerant of TMP/SMX require an effective alternative. Dapsone and atovaquone have both shown promise as PCP prophylactic agents.

Patients are randomized to receive either dapsone or atovaquone daily, with follow-up at the clinic every 4 months.

Being tested
Atovaquone, Dapsone
Keywords
Pneumonia, Pneumocystis carinii, Dapsone, Antifungal Agents, Acquired Immunodeficiency Syndrome, atovaquone
Medical subject headings
Pneumonia, Pneumocystis, HIV Infections, Acquired Immunodeficiency Syndrome

What participants receive

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

  • AtovaquoneDrug

  • DapsoneDrug

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 completionJul 1997

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 3
Primary purpose
Treatment
Intervention model
Parallel groups
Enrolment
700 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00000802
Sponsor's protocol ID
ACTG 277
Other IDs
CPCRA 034, 11253
Status last verified
Oct 2021
First submitted
2 Nov 1999
Last updated
4 Nov 2021
Results posted
No

Publications

  • El-Sadr WM, Murphy RL, Yurik TM, Luskin-Hawk R, Cheung TW, Balfour HH Jr, Eng R, Hooton TM, Kerkering TM, Schutz M, van der Horst C, Hafner R. Atovaquone compared with dapsone for the prevention of Pneumocystis carinii pneumonia in patients with HIV infection who cannot tolerate trimethoprim, sulfonamides, or both. Community Program for Clinical Research on AIDS and the AIDS Clinical Trials Group. N Engl J Med. 1998 Dec 24;339(26):1889-95. doi: 10.1056/NEJM199812243392604.

    PubMed 9862944

  • Caldwell P, Murphy R, Chan C, Yurik T, Scott J, el-Sadr W. Atovaquone suspension (ATQ) for prophylaxis of Pneumocystis carinii pneumonia (PCP): effects of baseline prophylaxis on safety and efficacy. Int Conf AIDS. 1998;12:297 (abstract no 22178)

  • Murphy R, El-Sadr W, Cheung T, Luskin-Hawk R, Yurik T, Neaton J, Hafner R. Impact of protease inhibitor containing regimens on the risk of developing opportunistic infections and mortality in the CPCRA 034/ACTG 277 study. Conf Retroviruses Opportunistic Infect. 1998 Feb 1-5;5th:113 (abstract no 181)

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Atovaquone and Dapsone in people with Pneumonia, Pneumocystis Carinii and HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 44 sites in 2 countries.

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 11 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 4 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 44 sites in United States, Tanzania. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 NCT00000802, 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 4 Nov 2021.

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