Completed
THF Gamma 2 Impact on HIV Load in HIV-Positive Individuals with CD4+ Cell Counts of 200-500 Cells/mm3
What is being tested
Thymic Humoral Factor
+ Zidovudine
Drug
Who is being recruted
Blood-Borne Infections+11
+ Urogenital Diseases
+ Genital Diseases
Over 13 Years
+19 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 2
Interventional
Summary
Principal SponsorPharmacia
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner
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.
Principal SponsorPharmacia
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 13 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsHIV Infections
Criteria
9 inclusion criteria required to participate
HIV-1 positive PCR RNA.
Mean CD4 of 200-500 cells/mm3.
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.
HIV seropositivity and be either asymptomatic or have persistent generalized lymphadenopathy (PGL).
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10 exclusion criteria prevent from participating
Proteinuria > 1+.
Myositis within the past 6 months.
Prior antiretroviral therapy (AZT-naive patients only).
Active alcoholism, drug abuse, or a mental or psychiatric problem sufficient to prevent adequate compliance with study.
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Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 10 locations
Southwest Community Based AIDS Treatment Group - COMBAT
Los Angeles, United StatesSan Francisco Veterans Administration Med Ctr
San Francisco, United StatesGottlieb Med Group
Sherman Oaks, United StatesCompleted10 Study Centers