Three Chemo Regimens as an Adjunct to ART for Treatment of Advanced AIDS-KS

Inclusion Criteria for Step 1:

• HIV-1 infection
• Biopsy diagnostic of KS at any time prior to study entry.
• Current KS stage T1 using ACTG criteria.
• A minimum of five indicator KS cutaneous marker lesions plus an additional two lesions greater or equal to 4x4 mm that are accessible for punch biopsy.
• CD4+ lymphocyte cell count obtained within 28 days prior to study entry at a DAIDS-approved laboratory.
• Certain laboratory values, as defined in the protocol, obtained within 14 days prior to study entry.
• Cardiac ejection fraction of greater than or equal to 50% obtained within 14 days prior to study entry.
• Female study volunteers of reproductive potential must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL performed within 24 hours before initiating the protocol-specified medications.
• All participants must agree not to participate in a conception process (active attempt to become pregnant or to impregnate, donate sperm, in vitro fertilization).
• If participating in sexual activity that could lead to pregnancy, participant must agree that two reliable forms of contraceptives will be used simultaneously while receiving protocol-specified medications, and for 6 weeks after stopping the medications. Study volunteers who are not of reproductive potential (women who have been post-menopausal for at least 24 consecutive months or have undergone hysterectomy and/or bilateral oophorectomy or men who have documented azoospermia) are eligible without requiring the use of contraceptives.
• Ability to swallow oral medications and adequate venous access.
• Karnofsky performance status ≥ 60 within 28 days prior to entry.
• Ability and willingness of participant or legal guardian/representative to provide informed consent.

Exclusion Criteria for Step 1:

• Current chronic, acute, or recurrent serious infections for which the participant has not completed at least 14 days of therapy prior to Step 2 entry and/or is not clinically stable.
• Serious illness requiring systemic treatment and/or hospitalization within 14 days prior to entry.
• Current or history of known pulmonary fibrosis, chronic obstructive pulmonary disease (COPD), emphysema, bronchiectasis, or diffuse or significant local radiographic interstitial infiltrates on chest x-ray (CXR) or computed axial tomography (CAT).
• Oxygen saturation less than 90% and/or exercise desaturation greater than 4% within 14 days prior to study enrollment.
• Grade ≥3 peripheral neuropathy (PN) at entry.
• Breastfeeding.
• Receipt of ART for more than 28 days immediately prior to entry.
• Prior or current systemic or locally administered chemotherapy.
• Prior or current radiation therapy.
• Prior or current immunotherapy, e.g., interferon alfa.
• Corticosteroid use at doses above those given as replacement therapy for adrenal insufficiency within the last 30 days prior to study entry.
• Any immunomodulator, HIV vaccine, live attenuated vaccines, or other investigational therapy or investigational vaccine within 30 days prior to study entry.
• Known allergy/sensitivity or any hypersensitivity to components of study drugs or their formulation.
• Active drug or alcohol use or dependence that would interfere with adherence to study requirements.
• Current or anticipated receipt of any of the prohibited medications listed in section 5.5.2 of the protocol.
• In the opinion of the investigator, any psychological or social condition, or addictive disorder that would preclude compliance with the protocol.
• New York Heart Association Functional Class II-IV heart failure.