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COMPLETEDPHASE2

A Study of Thymic Humoral Factor (THF Gamma 2) in HIV-Infected Patients

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

NCT00002435•Pharmacia

View on ClinicalTrials.gov

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

Age

13 - No limit years

Sex

ALL

Healthy Volunteers

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.
+2 more criteria

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:
+8 more criteria

Locations (10)

UCI

Irvine, California, United States

Southwest Community Based AIDS Treatment Group - COMBAT

Los Angeles, California, United States

San Francisco Veterans Administration Med Ctr

San Francisco, California, United States

Gottlieb Med Group

Sherman Oaks, California, United States

Mem Hosp Hollywood

Hollywood, Florida, United States

Goodgame Med Group

Maitland, Florida, United States

Chelsea Village Med Ctr

New York, New York, United States

Portland Veterans Adm Med Ctr / Rsch & Education Grp

Portland, Oregon, United States

Dr Alfred F Burnside Jr

Columbia, South Carolina, United States

Infectious Disease Physicians Inc

Annandale, Virginia, United States

Key Dates

Last Updated

June 24, 2005

Conditions

HIV Infections

Interventions

Thymic Humoral Factor

DRUG

Zidovudine

DRUG

Skeletal Muscle Energetics and Fatiguability in Older Individuals

NCT04142047

HIVHIV Infections

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RECRUITINGPHASE3

A Study to Evaluate the Effectiveness of Long-acting (LA) Cabotegravir (CAB) + Rilpivirine (RPV) LA When Given to Participants With Detectable HIV-1

NCT06694805

HIV Infections

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RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 24, 2005Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Study of Thymic Humoral Factor (THF Gamma 2) in HIV-Infected Patients

Inclusion Criteria

Exclusion Criteria

Skeletal Muscle Energetics and Fatiguability in Older Individuals

A Study to Evaluate the Effectiveness of Long-acting (LA) Cabotegravir (CAB) + Rilpivirine (RPV) LA When Given to Participants With Detectable HIV-1

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