HIV Infections
Conditions
Keywords
Drug Therapy, Combination, Antiviral Agents, Zidovudine, thymic humoral factor gamma 2
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.
Interventions
DRUGThymic Humoral Factor
DRUGZidovudine
Sponsors
Pharmacia
Study design
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
13 Years to No maximum
Healthy volunteers
No
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.
Countries
United States
Outcome results
None listed