Clinical trial 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)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lymphatic Disease
HIV Infections
Keywords: Acquired Immunodeficiency Syndrome
Zidovudine
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

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