HIV InfectionsPhase 2NCT00002435
A Study of Thymic Humoral Factor (THF Gamma 2) in HIV-Infected Patients
A Phase 2 study testing Thymic Humoral Factor and Zidovudine in people with HIV Infections, run by Pharmacia at 10 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Thymic Humoral Factor and Zidovudine
- How many people
- Not given
- Where
- 10 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- Malignancy.
- Hematuria.
- Proteinuria > 1+.
- Concurrent Medication:
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- 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.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Infectious Disease Physicians Inc
Annandale, Virginia, 22203
Dr Alfred F Burnside Jr
Columbia, South Carolina, 29204
Mem Hosp Hollywood
Hollywood, Florida, 33021
UCI
Irvine, California, 92717
Southwest Community Based AIDS Treatment Group - COMBAT
Los Angeles, California, 90028
Goodgame Med Group
Maitland, Florida, 32751
Chelsea Village Med Ctr
New York, New York, 10014
Portland Veterans Adm Med Ctr / Rsch & Education Grp
Portland, Oregon, 97210
San Francisco Veterans Administration Med Ctr
San Francisco, California, 94121
Gottlieb Med Group
Sherman Oaks, California, 91403
About this study
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
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.
Read the 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.
- Conditions
- HIV Infections
- Being tested
- Thymic Humoral Factor, Zidovudine
- Keywords
- Drug Therapy, Combination, Antiviral Agents, Zidovudine, thymic humoral factor gamma 2
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thymic Humoral FactorDrug
ZidovudineDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Pharmacia
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002435
- Sponsor's protocol ID
- 136A
- Other IDs
- CS 112010-999
- Status last verified
- Feb 1998
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00002435
- Acronym / sponsor ID
- 136A
- Conditions
- HIV Infections
- Keywords
- Drug Therapy, Combination, Antiviral Agents, Zidovudine, thymic humoral factor gamma 2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- PharmaciaIndustry (pharma, biotech, devices)
- First posted
- 31 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Masking
- Double blind
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
- 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.
Key exclusion criteria (18 listed)
- Malignancy.
- Hematuria.
- Proteinuria > 1+.
- Non-antiretroviral agents with known or suspected activity against HIV.
- Investigational new drugs that are not antiretroviral agents distributed under a Treatment IND.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thymic Humoral Factor | Drug | – |
| Zidovudine | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Thymic Humoral Factor and Zidovudine in people with HIV Infections, run by Pharmacia at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.