Please select the arm or intervention descriptions that belong 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: Arm Label: Single dose of mebendazole; Type: ACTIVE_COMPARATOR; Interventions: Drug: Treatment with one of the two regimens of mebendazole | Arm Label: Multiple dose of mebendazole; Type: ACTIVE_COMPARATOR; Interventions: Drug: Treatment with one of the two regimens of mebendazole | Intervention Type: DRUG; Name: Treatment with one of the two regimens of mebendazole; Assigned to Arm(s): Multiple dose of mebendazole, Single dose of mebendazole
B: Arm Label: placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: vitamin A supplement; Type: ACTIVE_COMPARATOR; Interventions: Drug: vitamin A supplements | Intervention Type: DRUG; Name: vitamin A supplements; Assigned to Arm(s): vitamin A supplement | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): placebo
C: Arm Label: Papaya seed porridge; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Ujiplus | Arm Label: Albendazole and Plain porridge; Type: ACTIVE_COMPARATOR; Interventions: Drug: Albendazole | Arm Label: Plain porridge; Type: PLACEBO_COMPARATOR; Interventions: Dietary Supplement: uji | Intervention Type: DIETARY_SUPPLEMENT; Name: Ujiplus; Assigned to Arm(s): Papaya seed porridge | Intervention Type: DRUG; Name: Albendazole; Assigned to Arm(s): Albendazole and Plain porridge | Intervention Type: DIETARY_SUPPLEMENT; Name: uji; Assigned to Arm(s): Plain porridge
D: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Drug: Albendazole, Drug: Praziquantel | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Drug: Current standard of care in Kenya | Intervention Type: DRUG; Name: Albendazole; Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: Praziquantel; Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: Current standard of care in Kenya; Assigned to Arm(s): 2

Answer: D