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)

HIV Infections Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002048
• Other study ID #: 014J
• Secondary ID: 21
• Status: Completed
• Phase: N/A
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: September 1989
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years and older

Eligibility

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.

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections
• Lymphatic Disease
• Lymphatic Diseases

Intervention

Drug:
• Zidovudine

Locations

Country	Name	City	State
United States	Univ of New Mexico Hlth Sciences Ctr / Dept of Med	Albuquerque	New Mexico
United States	Emory Univ School of Medicine	Atlanta	Georgia
United States	Med Univ of South Carolina	Charleston	South Carolina
United States	Nalle Clinic	Charlotte	North Carolina
United States	Univ TX Galveston Med Branch	Galveston	Texas
United States	Baylor College of Medicine	Houston	Texas
United States	LaJolla Veterans Administration Med Ctr	LaJolla	California
United States	Northshore Hosp / Cornell Univ	Manhasset	New York
United States	Regional Med Ctr at Memphis	Memphis	Tennessee
United States	Univ of Miami School of Medicine	Miami	Florida
United States	Milwaukee County Med Complex	Milwaukee	Wisconsin
United States	Buckley Braffman Stern Med Associates	Philadelphia	Pennsylvania
United States	Graduate Hosp	Philadelphia	Pennsylvania
United States	Good Samaritan Hosp	Portland	Oregon
United States	Oregon Health Sciences Univ	Portland	Oregon
United States	Med College of Virginia	Richmond	Virginia
United States	Dr Kristen Reis	Salt Lake City	Utah
United States	Univ of Utah School of Medicine	Salt Lake City	Utah
United States	AIDS Clinical Trials Group	San Diego	California
United States	Univ of South Florida	Tampa	Florida
United States	Georgetown Univ Med Ctr	Washington	District of Columbia
United States	Bowman Gray School of Medicine / North Carolina Baptist Hosp	Winston Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Glaxo Wellcome

Country where clinical trial is conducted

United States,