Current partner codePEPTIDESDE
NCT00001036·Phase 1·INTERVENTIONAL

The Safety and Effectiveness of a Type of Interleukin-2 Plus Zidovudine Plus Thymosin in HIV-Positive Patients With and Without Symptoms of Infection

Status

Completed

Phase

Phase 1

Enrollment

12

Locations

1

Results

Not posted

Publications

1

Study summary

What the protocol is testing.

To determine the safety of thymosin alpha 1 given twice weekly in a regimen of daily oral zidovudine (AZT) and biweekly polyethylene glycolated interleukin-2 (PEG IL-2). To determine the effect of thymosin alpha 1 and PEG IL-2 in combination with AZT on immunologic and pharmacokinetic markers. AIDS is characterized by diminished T helper cell number and function. Thymosin alpha 1 appears to both increase IL-2 receptors on lymphocytes in vitro and enhance lymphocyte maturation in vivo; thus, the drug may further enhance the CD4 T cell levels in patients receiving AZT and PEG IL-2.

Full detailed description

AIDS is characterized by diminished T helper cell number and function. Thymosin alpha 1 appears to both increase IL-2 receptors on lymphocytes in vitro and enhance lymphocyte maturation in vivo; thus, the drug may further enhance the CD4 T cell levels in patients receiving AZT and PEG IL-2. Patients are stabilized on oral AZT daily for 8 weeks and then begin receiving bolus infusions of PEG IL-2 every other week for at least four doses. Thymosin alpha 1 (given SC) is then added to this regimen twice weekly for 4 weeks. If no significant toxicity occurs, thymosin alpha 1 is increased to and administered along with scheduled doses of PEG IL-2 for an additional 8 weeks.

Interventions

Treatment arms and agents.

DRUG

Thymalfasin

DRUG

Interleukin-2, Polyethylene Glycolated

DRUG

Zidovudine

Timeline

From registration to results.

  1. First posted

    Aug 31, 2001

  2. Study start

    Not reported

  3. Primary completion

    Not reported

  4. Study completion

    Not reported

  5. Results posted

    Not reported

  6. Registry updated

    Jul 30, 2008

Outcomes

What the study measures.

Primary outcomes

Not reported in the indexed record.

Secondary outcomes

Not reported in the indexed record.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

Inclusion Criteria Concurrent Medication: Allowed: * Prophylactic pentamidine for Pneumocystis carinii. Patients must have: * HIV seropositivity. * CD4 count \> 50 and \< 200 cells/mm3. * No active opportunistic infections. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: * Concurrent neoplasms other than basal cell carcinoma of the skin, in situ carcinoma of the cervix, or Kaposi's sarcoma. * Significant cardiac disease or CNS lesions or other neurologic abnormalities. * Score of \> 0.5 on ACTG AIDS Dementia Complex staging. * Major organ allograft. * Intolerance to AZT at 500 mg/day. Concurrent Medication: Excluded: * Antihypertensive medication other than diuretics. * Chemotherapy, hormonal therapy, or other immunotherapy. * Other investigational drugs, agents, or devices. * Beta-blockers. * Non-topical steroids. Concurrent Treatment: Excluded: * Radiation therapy. Prior Medication: Excluded: * Known anti-HIV medication (other than AZT) or known immunomodulators (e.g., systemic steroids, interferons, interleukins) or other chemotherapy within 30 days prior to study entry. Prior Treatment: Excluded: * Transfusion within 4 weeks prior to study entry. * Radiation within 30 days prior to study entry. Active substance abuse.

Study locations

1 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

Stanford Univ Med Ctr

Stanford, California, United States

Related trials

More studies on Thymosin Alpha-1.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.