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)

Sponsor

Glaxo Wellcome (Industry)

Overall Status

Completed

CT.gov ID

NCT00002048

Collaborator

(none)

Locations

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lymphatic Disease HIV Infections	Drug: Zidovudine	N/A

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

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)

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years to 0 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	LaJolla Veterans Administration Med Ctr	LaJolla	California	United States	92037
2	AIDS Clinical Trials Group	San Diego	California	United States	92103
3	Georgetown Univ Med Ctr	Washington	District of Columbia	United States	20007
4	Univ of Miami School of Medicine	Miami	Florida	United States	331361013
5	Univ of South Florida	Tampa	Florida	United States	33612
6	Emory Univ School of Medicine	Atlanta	Georgia	United States	30303
7	Univ of New Mexico Hlth Sciences Ctr / Dept of Med	Albuquerque	New Mexico	United States	87131
8	Northshore Hosp / Cornell Univ	Manhasset	New York	United States	11030
9	Nalle Clinic	Charlotte	North Carolina	United States	28207
10	Bowman Gray School of Medicine / North Carolina Baptist Hosp	Winston Salem	North Carolina	United States	27103
11	Oregon Health Sciences Univ	Portland	Oregon	United States	97201
12	Good Samaritan Hosp	Portland	Oregon	United States	972103079
13	Buckley Braffman Stern Med Associates	Philadelphia	Pennsylvania	United States	19107
14	Graduate Hosp	Philadelphia	Pennsylvania	United States	19146
15	Med Univ of South Carolina	Charleston	South Carolina	United States	29425
16	Regional Med Ctr at Memphis	Memphis	Tennessee	United States	38103
17	Univ TX Galveston Med Branch	Galveston	Texas	United States	77550
18	Baylor College of Medicine	Houston	Texas	United States	77030
19	Dr Kristen Reis	Salt Lake City	Utah	United States	84132
20	Univ of Utah School of Medicine	Salt Lake City	Utah	United States	84132
21	Med College of Virginia	Richmond	Virginia	United States	23298
22	Milwaukee County Med Complex	Milwaukee	Wisconsin	United States	53226