Clinical trial NCT00002290: The Safety and Effectiveness of Zidovudine Plus Acyclovir in Patients With Early HIV Infection
Official title: A Multi-Center, Double-Blind Trial to Evaluate the Safety and Efficacy of Concurrent Retrovir (Zidovudine) and Zovirax (Acyclovir) Therapy in Patients With Early Symptomatic Human Immunodeficiency Virus (HIV) Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: AIDS-Related Opportunistic Infections
Drug Therapy, Combination
Acyclovir
AIDS-Related Complex
Zidovudine
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: This double-blind, placebo-controlled study is designed to determine the long-term safety and efficacy of concurrent oral Retrovir / Zovirax (AZT and ACV) therapy and oral AZT therapy alone, in the treatment of early symptomatic HIV infection. Efficacy will be evaluated by monitoring the incidence, severity, and time of development of opportunistic infections and other manifestations of advanced symptomatic HIV infection. The effects of the combination and single AZT therapy on immune function and viral replication will also be evaluated. Study participants will be monitored for evidence of toxicity or intolerance to concurrent AZT / ACV administration and AZT therapy alone.


Eligibility criteria: Inclusion Criteria

Patients must have:

* Early AIDS related complex (ARC).
* Willingness to be followed by the original study center for the duration of the trial (96 weeks).
* Ability to give informed consent.
* Patients may have associated lymphadenopathy (lymph nodes greater than or equal to 1 cm in two noncontiguous areas).

Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

* Concurrent neoplasms other than basal cell carcinoma of the skin or in situ carcinoma of the cervix.
* Fever \> 102 degrees F persisting for more than 14 consecutive days or more than 15 days in a 30-day interval, present at entry.
* Severe malabsorption (evidenced by persistent diarrhea of greater than 4 weeks duration with = or \> 6 loose stools per day accompanied by significant weight loss).

Concurrent Medication:

Excluded:

* Acyclovir (ACV) therapy for chronic or recurrent herpes simplex.

Patients with an AIDS-defining indicator disease as outlined by the CDC surveillance definition for AIDS which includes opportunistic infections or neoplasms, HIV neurologic disease, AIDS dementia or the "wasting syndrome" are excluded.

Prior Medication:

Excluded within 4 weeks of study entry:

* Any other experimental therapy.
* Drugs which cause significant bone marrow suppression.
* Rifampin or rifampin derivatives.
* Cytolytic chemotherapy.
* Drugs which cause significant nephrotoxicity or hepatotoxicity.
* Immunomodulating agents, including steroids, interferon, Isoprinosine, immunoglobulin or interleukin 2.
* Excluded within 8 weeks of study entry:
* Antiretroviral agents.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Birmingham Veterans Administration Med Ctr / Univ of Alabama
state: Alabama
city: Tucson
country: United States
facility: Univ of Arizona / Health Science Ctr
state: Arizona
city: San Francisco
country: United States
facility: ViRx Inc
state: California
city: Washington
country: United States
facility: Georgetown Univ Med Ctr / Main Hosp 4
state: District of Columbia
city: Bay Pines
country: United States
facility: Veterans Administration Med Ctr
state: Florida
city: Chicago
country: United States
facility: Rush Presbyterian - Saint Luke's Med Ctr
state: Illinois
city: Detroit
country: United States
facility: Harper Hosp
state: Michigan
city: Philadelphia
country: United States
facility: Univ of Pennsylvania / HIV Clinic
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt School of Medicine
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: Univ of Utah School of Medicine
state: Utah
city: Charlottesville
country: United States
facility: Univ of Virginia Health Sciences Ctr
state: Virginia
city: Richmond
country: United States
facility: Richmond AIDS Consortium
state: Virginia
Study officials:
References: