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A Randomized Comparison of Three Regimens of Chemotherapy With Compatible Antiretroviral Therapy for Treatment of Advanced AIDS-KS in Resource-Limited Settings

Phase 3
18 Years
Not Enrolling
HIV-1 Infection

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Trial Information

A Randomized Comparison of Three Regimens of Chemotherapy With Compatible Antiretroviral Therapy for Treatment of Advanced AIDS-KS in Resource-Limited Settings

Inclusion Criteria

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

- 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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Lack of clinical efficacy

Outcome Description:

Clinical efficacy is defined as Kaposi's Sarcoma (KS) progression, death by week 48, entry into an additional step prior to week 48, or loss to follow-up.

Outcome Time Frame:

48 weeks

Safety Issue:


Principal Investigator

Margaret Borok-Williams, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Zimbabwe


United States: Federal Government

Study ID:

ACTG A5263



Start Date:

February 2013

Completion Date:

August 2020

Related Keywords:

  • HIV-1 Infection
  • HIV Infections