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- Klinische proef NCT00002048
The Efficacy and Safety of Retrovir in Patients Infected With HIV Who Are Asymptomatic (CDC Group II) or Have Persistent Generalized Lymphadenopathy (CDC Group III)
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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California
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LaJolla, California, Verenigde Staten, 92037
- LaJolla Veterans Administration Med Ctr
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San Diego, California, Verenigde Staten, 92103
- AIDS Clinical Trials Group
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District of Columbia
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Washington, District of Columbia, Verenigde Staten, 20007
- Georgetown Univ Med Ctr
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Florida
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Miami, Florida, Verenigde Staten, 331361013
- Univ of Miami School of Medicine
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Tampa, Florida, Verenigde Staten, 33612
- Univ of South Florida
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Georgia
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Atlanta, Georgia, Verenigde Staten, 30303
- Emory Univ School of Medicine
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New Mexico
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Albuquerque, New Mexico, Verenigde Staten, 87131
- Univ of New Mexico Hlth Sciences Ctr / Dept of Med
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New York
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Manhasset, New York, Verenigde Staten, 11030
- Northshore Hosp / Cornell Univ
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North Carolina
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Charlotte, North Carolina, Verenigde Staten, 28207
- Nalle Clinic
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Winston Salem, North Carolina, Verenigde Staten, 27103
- Bowman Gray School of Medicine / North Carolina Baptist Hosp
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Oregon
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Portland, Oregon, Verenigde Staten, 97201
- Oregon Health Sciences Univ
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Portland, Oregon, Verenigde Staten, 972103079
- Good Samaritan Hosp
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Pennsylvania
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Philadelphia, Pennsylvania, Verenigde Staten, 19146
- Graduate Hosp
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Philadelphia, Pennsylvania, Verenigde Staten, 19107
- Buckley Braffman Stern Med Associates
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South Carolina
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Charleston, South Carolina, Verenigde Staten, 29425
- Med Univ of South Carolina
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Tennessee
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Memphis, Tennessee, Verenigde Staten, 38103
- Regional Med Ctr at Memphis
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Texas
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Galveston, Texas, Verenigde Staten, 77550
- Univ TX Galveston Med Branch
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Houston, Texas, Verenigde Staten, 77030
- Baylor College of Medicine
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Utah
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Salt Lake City, Utah, Verenigde Staten, 84132
- Univ of Utah School of Medicine
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Salt Lake City, Utah, Verenigde Staten, 84132
- Dr Kristen Reis
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Virginia
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Richmond, Virginia, Verenigde Staten, 23298
- Med College of Virginia
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Wisconsin
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Milwaukee, Wisconsin, Verenigde Staten, 53226
- Milwaukee County Med Complex
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Exclusion Criteria
Co-existing Condition:
Patients with the following are excluded:
- Prior history of a malignancy other than cutaneous basal cell or cervical carcinomas.
- Other significant, chronic underlying medical illness which would impair study completion.
- Liver dysfunction as demonstrated by lab results.
- Laboratory evidence of compromised bone marrow function.
Concurrent Medication:
Excluded:
- Any other experimental agents.
- Any probenecid-containing product.
Patients are excluded if they have a history of symptoms characteristic of CDC class I or IV including any of the following:
- Unintentional weight loss of greater than 10 lbs, or more than 10 percent of usual body weight within the last 16 weeks.
- Unexplained fever > 38.5 degrees C on more than 14 consecutive days or on more than 15 days in the previous 30-day period.
- Unexplained diarrhea defined by = or > 2 liquid stools per day persisting for = or > 14 days or 15 days in any 30-day period.
- OR History of secondary infections associated with AIDS related complex (ARC) including:
- Recurrent oral candidiasis documented by morphology or by response to antifungal therapy within 3 years.
- Herpes zoster infection within 3 years.
- Oral hairy leukoplakia at any time.
- OR History of opportunistic disease fulfilling the CDC surveillance definition of AIDS.
- Signs and symptoms at baseline characteristic of acute HIV disease (CDC group I).
- Evidence of significant neurologic dysfunction as currently defined by CDC following standard neurologic screening and AIDS Dementia Assessment.
Prior Medication:
Excluded:
- Previous treatment for greater than 3 months duration with any antiretroviral compound such as zidovudine (AZT).
Excluded within 4 weeks of study entry:
- Treatment with any potentially myelosuppressive drug, nephrotoxic agent, or other experimental therapy.
Excluded within 3 months of study entry:
- Antiretroviral drugs or biologic response modifiers.
Excluded within 4 months of study entry:
- Systemic corticosteroids.
Patients must meet the following criteria:
- HIV infection demonstrated by ELISA and confirmed by Western blot.
- Signs and symptoms of HIV disease limited to those characteristic of CDC groups II (asymptomatic) and III (persistent generalized lymphadenopathy - PGL).
- Ability to give informed consent.
- Willingness to be followed by the originating medical center for the entire 3-year duration of the study.
Active drug or alcohol abuse sufficient in the investigator's opinion to prevent compliance with the study regimen.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
Medewerkers en onderzoekers
Sponsor
Studie record data
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 014J
- 21
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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