Please select the eligibility criteria that correspond to the clinical trial below.
Title: Empiric Therapy of Helminth Co-infection to Reduce HIV-1 Disease Progression
Brief Summary: Abstract:

Over 25 million HIV-1 infected individuals are currently living in Africa and as many as 50-90% may be co-infected with soil transmitted helminths such as roundworms, hookworms or whipworms. Helminth infection in HIV-1-infected individuals may increase HIV-1 RNA levels and increase the rate of progression of HIV-1 to AIDS. Studies have also shown that successful treatment of helminth co-infection (as documented by clearance of helminth eggs in stool) led to a significant decrease in HIV-1 plasma viral load (-0.36 log10). This change in viral load was significantly greater than that seen in those individuals without documented clearance of their helminth co-infection (+0.67 log10) (p=0.04). Studies conducted in Africa have shown an estimated 2.5-fold increased risk for sexual transmission of the HIV-1 for each log increase in plasma HIV-1 viral load. In addition to direct effects on plasma viral load, the rate of CD4 cell decline in helminth infected individuals may be directly impacted by the significant immune activation seen with such co-infection.

The investigators propose a randomized controlled trial examining the potential benefits of routine empiric helminth eradication in HIV-1 infected adults who do not yet qualify for antiretroviral (ARV) therapy in Kenya. The current standard of care of symptomatic diagnosis and treatment will be compared to a systematic empiric scheduled de-worming program for HIV infected adults. The investigators will compare markers of disease progression including rate of CD4 decline and changes in HIV-1 RNA levels between the two treatment arms.


Options:
A: Inclusion Criteria:

* Written informed consent signed by parents and/or caregiver; and oral assent by participant.
* Able and willing to be examined by a study physician at the beginning of the study.
* Able and willing to provide two stool samples at the beginning (baseline) and approximately three weeks after treatment (follow-up).
* Positive for hookworm eggs in the stool (≥ 100 EPG and at least two Kato-Katz thick smears slides with more than one hookworm egg).
* Absence of major systemic illnesses, e.g. diabetes, severe anemia (HB\<8.0 g/l) as assessed by a medical doctor at school, upon initial clinical assessment.
* No known or reported history of chronical illness as cancer, diabetes, chronic heart, liver or renal disease.
* No recent anthelminthic treatment (within past 4 weeks). No known allergy to study medications (mebendazole and albendazole).

Exclusion Criteria:

No written informed consent by parents and/or caregiver; no oral assent by participant.

* Menarche, based on self-report
* Presence of major systemic illnesses, e.g. diabetes, severe anemia (HB\<8.0 g/l) as assessed by a medical doctor, upon initial clinical assessment.
* History of acute or severe chronic disease.
* Recent use of anthelminthic drug (within past 4 weeks).
* Attending other clinical trials during the study.
* Negative diagnostic result for hookworm eggs in the stool (\< 100 EPG (total of the four slides) and/or only one Kato-Katz thick smear slide with more than one hookworm egg).
B: Inclusion Criteria:

* Age 7-12 years (according to birth date in birth certificate).
* No evidence of concomitant severe and/or chronic illness such as acute respiratory tract infections, mental retardation and neurological deficits.
* Consent of parent to participate in the study.

Exclusion Criteria:

* history or evidence of underlying haematological-related diseases such as thalassaemia and ovalocytosis.
* menstruating females (age \>13)
C: Inclusion Criteria:

* Consenting parents and guardians

Exclusion Criteria:

* children with known allergy to papaya fruit products
D: Inclusion Criteria:

* Participants must not be or have been on highly active antiretroviral therapy.
* Participants must have CD4 count \> 350 cells/mm3 in order to be enrolled in the randomized controlled trial.
* Participants must be at least 18 years of age.
* Participants must be able and willing to participate and give written informed consent.
* Participants must be able and willing to return for the scheduled follow-up visits.

Exclusion Criteria:

• Participants must not be pregnant at the time of enrollment (by urine HCG testing).

Answer: D