Clinical trial NCT00002435: A Study of Thymic Humoral Factor (THF Gamma 2) in HIV-Infected Patients
Official title: Study of the Activity of Thymic Humoral Factor (THF Gamma 2) on HIV Load in HIV-Positive Individuals With CD4+ Cell Counts in the Range of 200-500 Cells/mm3
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV Infections
Keywords: Drug Therapy, Combination
Antiviral Agents
Zidovudine
thymic humoral factor gamma 2
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 investigate the safety of thymic humoral factor (THF gamma 2), its effect on HIV load based on at least a 75 percent decrease in HIV quantitative PCR RNA copies/ml, and its persistence when administered in combination with an antiretroviral nucleoside derivative (zidovudine; AZT). To assess the effects of THF gamma 2 on T-cells, quality of life, and progression of disease.

Detailed description: All patients receive 12 weeks of AZT before being randomized to self-administer one of two doses of THF gamma 2 or placebo for 15 consecutive days and then twice weekly for an additional 50 weeks.

Eligibility criteria: Inclusion Criteria

Concurrent Medication:

Allowed:

* AZT or another antiretroviral agent (marketed or investigational under a Treatment IND).
* Primary prophylaxis for Pneumocystis carinii pneumonia (PCP), toxoplasmosis, and Mycobacterium avium-intracellulare (MAI) if patient's CD4 count decreases to \< 200 cells/mm3.
* Other marketed drugs as required.

Patients must have:

* HIV seropositivity and be either asymptomatic or have persistent generalized lymphadenopathy (PGL).
* No history of symptoms in Category B or C of 1993 Case Definition, other than oral candidiasis following previous broad-spectrum antibiotic therapy.
* Mean CD4 of 200-500 cells/mm3.
* HIV-1 positive PCR RNA.
* Ability to self-administer study drug by IM injection.
* Ability to tolerate AZT at 600 mg daily during first 8 weeks of run-in period (if AZT naive) OR tolerated AZT at \>= 500 mg daily for at least 3 months but no more than 12 months prior to randomization.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Malignancy.
* Hematuria.
* Proteinuria \> 1+.

Concurrent Medication:

Excluded:

* Non-antiretroviral agents with known or suspected activity against HIV.
* Investigational new drugs that are not antiretroviral agents distributed under a Treatment IND.

Patients with the following prior conditions are excluded:

Myositis within the past 6 months.

Prior Medication:

Excluded:

* Experimental therapy, including interleukin-2, interferon, erythropoietin, or filgrastim nucleoside within 6 weeks prior to study entry.
* Prior antiretroviral therapy (AZT-naive patients only).

Prior Treatment:

Excluded within 6 weeks prior to study entry:

* Blood transfusion or blood products. Active alcoholism, drug abuse, or a mental or psychiatric problem sufficient to prevent adequate compliance with study.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: UCI
state: California
city: Los Angeles
country: United States
facility: Southwest Community Based AIDS Treatment Group - COMBAT
state: California
city: San Francisco
country: United States
facility: San Francisco Veterans Administration Med Ctr
state: California
city: Sherman Oaks
country: United States
facility: Gottlieb Med Group
state: California
city: Hollywood
country: United States
facility: Mem Hosp Hollywood
state: Florida
city: Maitland
country: United States
facility: Goodgame Med Group
state: Florida
city: New York
country: United States
facility: Chelsea Village Med Ctr
state: New York
city: Portland
country: United States
facility: Portland Veterans Adm Med Ctr / Rsch & Education Grp
state: Oregon
city: Columbia
country: United States
facility: Dr Alfred F Burnside Jr
state: South Carolina
city: Annandale
country: United States
facility: Infectious Disease Physicians Inc
state: Virginia
Study officials:
References: