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AIDs is a set of symptoms (or syndrome) caused by Human Immunodeficiency Virus (HIV). The clinical features may be due to HIV per se or as a result of immune system destruction.


Diagnostic Criteria

  • Fever, diarrhoea, weight loss, skin rashes, sores, generalized pruritis, altered mental status, persistent severe headache, oral thrush or Kaposi’s sarcoma may be found in patients with advanced disease

  • Most patients, however, present with symptoms due to opportunistic infections e.g. tuberculosis, candidiasis or pyogenic infections 


• All HIV infected individuals are eligible for ART. Early initiation of combination treatment (ART) is associated with health benefits in terms of reduced morbidity and mortality in all age groups.

• Antiretroviral therapy (ART) has dramatically reduced HIV-associated morbidity and mortality and has transformed the HIV disease into a chronic, manageable condition. In addition, treatment of HIV-infected individuals with ART is highly efficient at preventing transmission to sexual partners and mother to child transmission (MTCT).  

Types of Antiretroviral Drugs 

The recommended antiretroviral drugs to be used in these guidelines fall into the following main categories:

  1. Nucleotide reverse transcriptase inhibitors (NRTIs) 

  2.  Nucleoside reverse transcriptase inhibitors (NRTIs)

  3. 1st and 2nd generation non-nucleoside reverse transcriptase inhibitors (NNRTIs) 

  4. Protease inhibitors (Pls)

  5.  Integrase strand transfer inhibitors (INSTI)/ Integrase inhibitors

  6.  Fusion inhibitors

  7.  Chemokine receptor inhibitors/CCR5 inhibitors 


Evaluation to be done before initiating ART

From the moment a patient tests HIV-positive, he/she should be linked to the Care and Treatment Clinic (CTC). In health facilities where ART is being initiated at RCH and TB clinics, patients can be managed at those clinics. Mobile outreach clinics can also be used where there are no static clinics.


First-Line Art Treatment

The following ARV drug combinations are recommended for first-line treatment for adults and adolescents:  


Recommended first-line regimens for adults and adolescents 


In the first two weeks of treatment only half of the required daily dose of Nevirapine should be administered. In cases where patients need switching from NVP due to severe NVP associated adverse effects such as Stevens-Johnson’s syndrome or hepatotoxicity, Efavirenz should not be used due to overlapping toxicities with Nevirapine. The patient should be introduced to DTG. 

ART in women of childbearing potential or pregnant women

Mother-to-child transmission (MTCT) of HIV refers to the transmission of HIV infections from HIV-infected mothers to their infants. MTCT can occur during pregnancy, labour and delivery, and breast-feeding. Without intervention, the overall risk of MTCT is approximately 20%–45%. However, with interventions, this risk can be reduced to less than 5%. Transmission of HIV from mother to her child accounts for over 90% of all HIV infections in children aged below 15 years.

Mother to Child Transmission of HIV             

mothr to child infection-ulyclinic.

Prevention of Mother to Child Transmission 

All HIV infected pregnant women and lactating mothers are eligible for ART regardless of CD4 cell count and clinical stage. The pregnant or breast-feeding women with HIV should be started on lifelong ART for their own health at the time of diagnosis.  

The recommended first-line regimen is once a day fixed dose combination regimen of Tenofovir (TDF) + Lamivudine (3TC) + Efavirenz (EFV). 

  • This regimen should be continued postpartum

  • Women should receive on-going counselling support to continue with HIV care and treatment in order to maintain good health and to reduce the risk of HIV transmission to others.

  • Available alternative first-line ART regimen includes AZT+3TC+NVP and AZT+3TC+EFV. 

Prophylaxis for HIV Exposed Infants

  • Administer NVP syrup immediately after birth to all HIV exposed infants and continue until six weeks of age

  • In case a high risk HIV exposed infant is identified, administer duo prophylaxis containing NVP syrup (once daily) and AZT syrup (twice daily) for the first 6 weeks of life, then continue with daily NVP alone up to 12 weeks of life 


High-risk infants are those who are:   

  • born to women with established HIV infections who have received less than 4 weeks of ART at the time of delivery; or

  • born to women with established HIV infection with viral load >1000 copies/mL in the 4 weeks before delivery, if viral load measurement is available; or

  • born to women with incident HIV infection during pregnancy or breastfeeding; or

  • Identified for the first time during the postpartum period, with or without a negative HIV test prenatally. 

  • Infant prophylaxis is most effective when given as soon as possible after birth, preferably within 6–12 hours

  • HIV exposed infants identified beyond the age of 4 weeks should not be given ARV prophylaxis 

NVP Dosing Recommendation     

The recommended NVP dosing is based on the dosing required to sustain exposure in the infant of >100 ng/mL with the fewest dose changes Low birth weight infants <2000g should receive mg/kg dosing; suggested starting dose is 2mg/kg once daily.  

Second-line Antiretroviral Therapy in Adults and Adolescents

Before treatment failure is confirmed and a particular regimen discarded, every effort should be made to rule out causes other than drug resistance. 

Drugs used as the second line in Tanzania include: 


  • Zidovudine (AZT) 300mg

  • Tenofovir (TDF) 300mg

  • Abacavir (ABC) 600mg

  • Lamivudine (3TC) 150mg

  • Emtricitabine (FTC)  200mg


  • Atazanavir 300mg boosted by Ritonavir 200mg (ATV/r) 

  • Lopinavir 800mg boosted by Ritonavir 200mg (LPV/r)


  • Dolutegravir 50 mg (DTG) 

Recommended second-line regimens for adults and adolescents

The second line NRTI choice for adults and adolescents depends on the first-line regimen.

For patients on TDF based regimens in first-line, the preferred second-line option is AZT plus 3TC combined with a ritonavir-boosted PI, preferably ATV/r because it is dosed once daily and has fewer metabolic complications and side effects.

The same NRTIs, with exception of 3TC and FTC used in previous regimen should not be used in subsequent regimens during switching due to treatment failure. LPV/r can be used as an alternative to ATV/r in patients using anti-TB drugs (with ritonavir super boosting) and children below 6 years. Also, ATV/r (300/100mg) cannot be used in children below 30kg. 

For patients who were on AZT and had never used TDF regimen, the default second-line option will be TDF or ABC based regimen combined with a boosted PI (TDF+FTC+ATV/r).  For patients who were introduced to TDF in first-line due to AZT toxicity, the default second-line option is to use ABC plus 3TC combined with a ritonavir-boosted PI ATV/r or LPV/r. (ABC + 3TC + LPV/r or ATV/r). However, ABC may be rendered ineffective due to cross resistance with TDF associated resistance mutations.

Note: ATV/r, LPV/r, ABC/3TC and TDF/FTC are currently available as FDC formulations which simplify dosing and administration.

Third-Line Art Treatment

Patients failing 2nd line regimens may have extensive NRTI and NNRTIs associated resistance mutations (RAMS) which preclude/minimise their use in third-line regimens.

Therefore, 3rd line regimens, in order to have at least two or preferably three effective drugs, need to be constructed using other new classes of drugs or second generation formulations of previous drugs. These second generation drugs usually have a higher genetic barrier to resistance and their efficacy is not compromised by RAMs associated with the first generation formulations.

Therefore, this guideline recommends the use of:

  • Integrase Inhibitors Dolutegravir 50mg (DTG) and Raltegravir 400mg (RAL),

  • Second generation PIs Darunavir 800mg /Ritonavir 100mg (DRV/r),

  • Second generation NNRTI Etravirine 200mg (ETV).

Recommended third-line regimens for adults and adolescents 


For second and third line regimens which are non TDF based, in case of new Hepatitis B co-infection TDF with FTC should be added to the new regimen as treatment of Hepatitis B



This can be grouped into two major categories:

Drug adverse events-toxicities

  • Intolerable side effects

  • Drug interactions

  • During pregnancy if patient is on EFV

Treatment failure

  • Clinical failure-occurrence or persistence of HIV related OIs

  • Immunological failure

  • Virological failure 

Changing antiretroviral therapy due to toxicity

From a clinical perspective, it is generally recommended that when changing a client’s regimen due to toxicity, only the toxic drug(s) should be replaced, wherever possible, by a drug without overlapping toxicities.

Table below provides guidance on ARV drug combinations with some common toxicity substitution within first-line regimens. 

Common toxicity substitution in first-line drugs 

firstline drugs-ulyclinic.JPG


For TB co-infected patients, the dose for DTG should be given twice daily i.e. 50mg bid      


Substitution within first-line Antiretroviral Regimens 


Types of toxicities associated with first and second-line ARV drugs 


Changing antiretroviral therapy due to treatment failure 

WHO definitions of treatment failure in chronological order of occurrence: virological, immunological and clinical failure for the decision to switch ART regimens 


Transient rises in viral load are called viral blips and are not due to treatment failure.

A diagnosis of treatment failure requires two consecutive viral load levels after >6months of treatment above 1000 copies/mL within an interval of 3 months and after adherence intensification.  

Treatment failure should be distinguished from IRIS in which case the viral load will be low and the CD4 cell count will be high.

Switching To Third-Line Arv Regimens

It is crucial that before a regimen is declared to have failed, a multidisplinary switch team is convened to rule out non-adherence which is the commonest cause of reduced CD4 cell count and a VL rise, but is often not associated with HIV drug resistance.

This team will also plan for enhanced adherence and support, for a period of 3 months before a second VL test. In case of non-adherence, these measures will lower the VL, increase CD4 cell count and avert a switch to a subsequent regimen   

Before switching to third-line ARV regimens, genotypic HIV drug resistance is recommended to rule cross resistance between 1st and 2nd generation drugs and also assist in the determination of whether treatment failure is from non-adherence. Genotyping will also inform possibility of recycling drugs used in previous regimens i.e. some drugs used in 1st or 2nd regimens may still be effective in third-line.


Monitoring of patients on ART is based on clinical and laboratory parameters.  

Clinical Monitoring: 

In most cases, treatment will be associated with weight gain and reduced morbidity from opportunistic infections and improvement in the quality of life. At each clinic visit, thorough history and physical examination should be done and recorded in the patient file. 

Laboratory Monitoring: 

  • Initiation of ART is done irrespective of CD4 cell count. Baseline CD4 cell count should nevertheless be determined to monitor immunological response. For patients with CD4 cell count less than 350 cell/mm3, the CD4+ T-lymphocyte count should be repeated after 6 months, until patient is stable CD4+ Tlymphocyte count more than 350cell/mm3 and two consecutive viral load less than 50copies/ml). However, in cases of suspected IRIS, CD4 can be tested at intervals less than six months. IRIS is diagnosed if CD4 cell count shows rising trends. 

  • Viral load (VL) testing is recommended as the preferred monitoring approach to diagnose and confirm treatment failure compared to immunological and clinical monitoring.

Clinical and laboratory monitoring of patients on first line drug regimen


NOTE: Clinical evaluation will determine more frequent laboratory tests if required.


Updated on, 31.10.2020


1. STG 

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