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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)

Information source: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Lymphatic Disease; HIV Infections

Intervention: Zidovudine (Drug)

Phase: N/A

Status: Completed

Sponsored by: Glaxo Wellcome

Summary

To evaluate the safety and tolerance of chronic administration of Retrovir (AZT) in HIV-infected adult patients without clinical manifestations of disease. To assess the efficacy of AZT therapy in the treatment of HIV disease in these patients.

Clinical Details

Official title: 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)

Study design: Primary Purpose: Treatment

Eligibility

Minimum age: 13 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Locations and Contacts

LaJolla Veterans Administration Med Ctr, LaJolla, California 92037, United States

AIDS Clinical Trials Group, San Diego, California 92103, United States

Georgetown Univ Med Ctr, Washington, District of Columbia 20007, United States

Univ of Miami School of Medicine, Miami, Florida 331361013, United States

Univ of South Florida, Tampa, Florida 33612, United States

Emory Univ School of Medicine, Atlanta, Georgia 30303, United States

Univ of New Mexico Hlth Sciences Ctr / Dept of Med, Albuquerque, New Mexico 87131, United States

Northshore Hosp / Cornell Univ, Manhasset, New York 11030, United States

Nalle Clinic, Charlotte, North Carolina 28207, United States

Bowman Gray School of Medicine / North Carolina Baptist Hosp, Winston Salem, North Carolina 27103, United States

Good Samaritan Hosp, Portland, Oregon 972103079, United States

Oregon Health Sciences Univ, Portland, Oregon 97201, United States

Buckley Braffman Stern Med Associates, Philadelphia, Pennsylvania 19107, United States

Graduate Hosp, Philadelphia, Pennsylvania 19146, United States

Med Univ of South Carolina, Charleston, South Carolina 29425, United States

Regional Med Ctr at Memphis, Memphis, Tennessee 38103, United States

Univ TX Galveston Med Branch, Galveston, Texas 77550, United States

Baylor College of Medicine, Houston, Texas 77030, United States

Dr Kristen Reis, Salt Lake City, Utah 84132, United States

Univ of Utah School of Medicine, Salt Lake City, Utah 84132, United States

Med College of Virginia, Richmond, Virginia 23298, United States

Milwaukee County Med Complex, Milwaukee, Wisconsin 53226, United States

Additional Information


Last updated: June 23, 2005

Page last updated: August 23, 2015

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